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359 death reports1987–20265 registriesClear
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Not graded by the source2023-12-22FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2024-10318da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA PROCEDURE, THE CANNULA SEAL ACCESSORY RIPPED WHILE THE CUSTOMER WAS INSERTING MESH INSIDE THE PATIENT WITH A GRASPER INSTRUMENT. DURING INSERTION OF THE GRASPER, THE CUSTOMER SAW A BLUE FRAGMENT/PIECE INSIDE THE PATIENT. THE CANNULA SEAL WAS INSPECTED, AND IT WAS NOTED TO BE TORN. IT IS UNKNOWN IF THERE WAS AN INSTRUMENT/ACCESSORY COLLISION. THE INSTRUMENT WRIST WAS STRAIGHTENED DURING REMOVAL. THE FRAGMENT WAS RETRIEVED USING A BACK-UP INSTRUMENT DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. THERE ARE NO PHOTOGRAPHIC IMAGES AVAILABLE.
cause not established2955842-2024-10318Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-20FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2024-18056da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2024-18056Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-20FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2024-10224da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT HAD A RECOGNITION ISSUE AND A FRAGMENT DETACHED FROM THE INSTRUMENT. THE FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH A NURSE FROM THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED BEFORE USE WITH NOTHING FOUND OUT OF THE ORDINARY. IT IS UNKNOWN WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON DOES NOT KNOW WHAT CAUSED THE ISSUE. THE ISSUE WITH THE INSTRUMENT OCCURRED ABOUT 10 MINUTES AFTER THE PROCEDURE STARTED. THE SURGEON DID NOT NOTICE FUNCTIONALITY ISSUES DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE INSTRUMENT WAS NOT REMOVED BEFORE BRAKEAGE AND THE WRIST WAS STRAIGHTENED. THE STAFF DID NOT FEEL RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE NOTED TO THE CANNULA. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED BY VISUAL INSPECTION. NO ADDITIONAL SURGICAL P
cause not established2955842-2024-10224Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-20FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2024-00276ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO THE ROBOT BECOMING UNRESPONSIVE, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.
cause not established3004142400-2024-00276Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2023-12-20FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2024-10195da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY PROCEDURE, THE SCRUB TECH NOTICED WHILE LOOKING INSIDE OF THE PELVIS OF THE PATIENT THAT A BLACK PIECE OF THE RUBBER PART OF THE UNIVERSAL SEAL FELL OFF INTO THE PATIENT. A GRASPER WAS UTILIZED TO REMOVE THE FRAGMENT FROM THE PATIENT. NO FRAGMENT WAS LEFT BEHIND INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO NOTED DAMAGE PRIOR TO USE OF THE CANNULA SEAL. THE SURGEON WAS UNSURE WHEN THE FRAGMENT FELL INSIDE THE PATIENT. HOWEVER, THE SURGEON SUSPECTED IT MAY HAVE BEEN OCCURRED WHEN INSERTING AN INSTRUMENT ONTO AN ARM AND THROUGH THE CAP OF THE CANNULA SEAL. THE PROCEDURE HAD BEEN IN PROGRESS FOR APPROXIMATELY 45 MINUTES WHEN THE EVENT OCCURRED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. IT WAS REPORTED THAT AN INSTRUMENT DID NOT BREAK. THE CANNULA SEAL WAS REMOVED AND REPLACED. THE AREA OF CANNULA SEAL WAS NOTED TO
cause not established2955842-2024-10195Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-20FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2024-00541ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT DOES NOT RECOGNIZE WHEN THE POWER CORD IS PLUGGED IN. WORKED FINE FOR A CASE LAST NIGHT, BUT WHEN TURNING ON TODAY TO DO A CASE IT WOULD NOT CHARGE THE BATTERY AND WAS RUNNING SOLELY OFF THE BATTERY WHEN TURNED ON. THINK A FUSE IS BLOWN IN THE ROBOT.
cause not established3004142400-2024-00541Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2023-12-19FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2024-18172da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT ELECTIVE LAPAROSCOPIC OR ROBOT-ASSISTED LAPAROSCOPIC HIATAL HERNIA (HH) REPAIR BETWEEN JANUARY 2020 AND DECEMBER 2022 WAS CONDUCTED TO EVALUATE THE CLINICAL EFFECTS OF ROBOT-ASSISTED LAPAROSCOPIC SURGERY (RALS) AND CONVENTIONAL LAPAROSCOPIC SURGERY (CLS) IN TREATING HH IN CHILDREN. FIFTY-FOUR PATIENTS WERE INITIALLY ENROLLED IN THE STUDY; HOWEVER, NINE PATIENTS WERE EXCLUDED DUE TO FACTORS SUCH AS GASTROESOPHAGEAL REFLUX (GER), SERIOUS DISEASES, AND INCOMPLETE CLINICAL DATA. ULTIMATELY, 46 PATIENTS MET THE INCLUSION CRITERIA, WITH 25 (54.3%) UNDERGOING CLS (GROUP 1) AND 21 UNDERGOING RALS (GROUP 2). THE AVERAGE AGE FOR GROUP 1 WAS 2.2 YEARS, WHILE FOR GROUP 2, IT WAS 3.3 YEARS. THE MEAN FOLLOW-UP PERIOD WAS 18 MONTHS FOR GROUP 1 AND 13 MONTHS FOR GROUP 2. POSTOPERATIVE COMPLICATIONS WERE ASSESSED, WITH PNEUMONIA BEING THE MOST COMMON IN BOTH GROUPS¿OCCURRING IN 5 PATIENTS (20%) IN GROUP 1 AND 2 PATIENTS (9.5%) IN GROUP 2. EACH GROUP HAD ONE PATIENT READMITTED DUE TO REPEATED VOMITING WITHIN ONE MONTH POST-OPERATION, BOTH OF WHOM RECOVERED WITH CONSERVATIVE TREATMENT. ADDITIONAL COMPLICATIONS INCLUDED ONE CASE OF PNEUMOTHORAX IN GROUP
cause not established2955842-2024-18172Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-18FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2024-00539ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT IS DISPLAYING A BLACK SCREEN WITH WHITE LETTERS ON BOOT UP SAYING "REBOOT AND SELECT PROPER BOOT DEVICE OR INSERT BOOT MEDIA IN SELECTED BOOT DEVICE AND PRESS A KEY".
cause not established3004142400-2024-00539Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2023-12-18FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2024-00540ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: (B)(6), LLIF L2-5 (FLUOROSCOPY WORKFLOW), PLDF L2-ILIUM (PREOP/INTRAOP WORKFLOW). FOR LLIF PORTION OF PROCEDURE FLUOROSCOPY WORKFLOW USED. L3/4 AND L4/5 REGISTERED AND L4/5 INSTRUMENTED FIRST. SURGEON STATED CAGE ENDED UP MORE POSTERIOR THAN PLANNED. L2/3 AND L3/4 REGISTERED AGAIN AND AGAIN, SURGEON STATED CAGE WAS PLACED MORE POSTERIORLY THAN NAVIGATION STATED. SURGEON DECLINED TO REGISTER L2/3 AGAIN AND CAGE PLACED. IN THE END, SURGEON STATED ALL CAGES WERE PLACED MORE POSTERIORLY THAN HE EXPECTED BASED ON THE NAVIGATION SHOWING HIM PLACING CAGES ANTERIOR TO FINAL POSITION.
cause not established3004142400-2024-00540Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2023-12-15FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical SystemMW5149649da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MY MOTHER SUFFERED SERIOUS COMPLICATIONS DURING A FUNDOPLICATION SURGERY USING THE DA VINCI ROBOT MADE MY INTUITIVE SURGICAL. A PRIMARY BLOOD VESSEL TO HER STOMACH WAS SEVERED CAUSING THE ORGAN TO DIE. SHE HAS CONTINUED TO HAVE ISSUES WITH PERFUSION TO HER INTESTINES REQUIRING MULTIPLE FOLLOW UP PROCEDURES TO REMOVE MORE NECROTIC TISSUE. AT THIS POINT WE ARE UNSURE IF SHE WILL SURVIVE AND IF SHE DOES SHE WILL BE DEPENDENT ON OTHERS FOR HER CARE FOR THE REMAINDER OF HER LIFE. SHE WAS PREVIOUSLY AN ACTIVE 65 YO GRANDMOTHER. THIS MATTER NEEDS TO BE INVESTIGATED FULLY. THE PROCEDURE WAS DONE BY DR (B)(6) AT (B)(6) HOSPITAL IN (B)(6). PROCEDURE DATE IS (B)(6) 2023.
cause not establishedMW5149649Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-15FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2024-00262ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR.
cause not established3004142400-2024-00262Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2023-12-15FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2024-11083da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT'S BLADE SUDDENLY BROKE. FRAGMENTS WERE REPORTED TO HAVE FALLEN INSIDE THE PATIENT AND WERE RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER USED A SPARE INSTRUMENT TO COMPLETE THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
cause not established2955842-2024-11083Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-15FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2024-00536ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT BROUGHT INTO ROOM AND TURNED ON WITHOUT ANY ISSUES. SCREEN WENT TO A BLUE SCREEN WITH MESSAGE "A START UP ERROR HAS OCCURRED". TRIED MULTIPLE RESTARTS AND ERROR STILL OCCURRED. CASE HAD TO BE ABORTED.
cause not established3004142400-2024-00536Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2023-12-14FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2024-00538ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A DBS PROCEDURE AN IDENTICAL BILATERAL DEVIATION WAS NOTICED EVEN WITH 3 REGISTRATIONS. THE PATIENT HAD A BONE FIDUCIAL PLACED AND AN INITIAL NON-STERILE REGISTRATION WITH O ARM SET TO THE STEREOTAXY SETTINGS WAS PERFORMED AND ACCURACY CHECKS WERE PERFORMED. IT WAS NOTICED THAT THE INITIAL REGISTRATION FIT WAS NOT CENTERED ON ALL SPHERES AND REQUIRED A FAIR AMOUNT OF MANIPULATION TO GET INTO A GREEN FIT. ACCURACY CHECKS WERE PERFORMED, INCLUDING WITH THE BONE FIDUCIAL AND SHOWED AN ACCEPTABLE REGISTRATION. THE PATIENT WAS DRAPED AND ACCURACY CHECKS WERE PERFORMED AGAIN SHOWING NO CHANGE IN ACCURACY. THE BURR HOLES WERE CREATED AT WHICH POINT THE PATIENT COUGHED. I ADVISED TO PERFORM ADDITIONAL ACCURACY CHECKS TO THE BONE FIDUCIAL SHOWING A 2-3 MM SHIFT POSTERIOR. A STERILE ICT AND ARM WERE ATTACHED AND ANOTHER O ARM SCAN WITH THE SAME SETTING WAS PERFORMED. THERE WAS A SIMILAR REGISTRATION FIT WITH THIS REGISTRATION AS WELL. ACCURACY CHECKS WERE PERFORMED AND THE LEAD WAS PERFORMED ON THE RIGHT SIDE. AN EVALUATION SCAN WAS PERFORMED SHOWING A 3 MM POSTERIOR MEDIAL DEVIATION. THE LEAD WAS LEFT DUE TO RESPONSIVE TESTING. THE PATIENT COUGHED AGAIN AND ANOTHER REGISTRATION WAS P
cause not established3004142400-2024-00538Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2023-12-14FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2024-10106da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP WAS BROKEN. A FRAGMENT FELL INSIDE THE PATIENT AND THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE HARMONIC ACE INSTRUMENT WAS INSPECTED BEFORE USE. THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS OR TOOLS.
cause not established2955842-2024-10106Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-13FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2024-15517da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL HYSTERECTOMY SURGICAL PROCEDURE, THE USER OBSERVED AN INSTRUMENT RECOGNITION ISSUE WITH THE HARMONIC ACE INSTRUMENT. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT A FRAGMENT OF THE TEFLON PAD PIECE WAS FOUND AND RETRIEVED. AN X-RAY TEST WAS PERFORMED TO CHECK FOR REMAINING FRAGMENTS INSIDE THE PATIENT. THERE WAS NO INSTRUMENT COLLISION.
cause not established2955842-2024-15517Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-13FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2023-21935da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA TRANSABDOMINAL PRE-PERITONEAL (TAPP) SURGICAL PROCEDURE, THE UNIVERSAL SEAL INSUFFLATION PORT BROKE OFF DURING CASE. A FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
cause not established2955842-2023-21935Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-12FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2023-21918da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2023-21918Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-12FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2023-21729da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT SLEEVE ON THE JOINT CAME OFF IN THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.
cause not established2955842-2023-21729Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-12FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2023-21948da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2023-21948Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-12FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2023-21603da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY, INSTALLED ON AN MCS INSTRUMENT, FELL OFF INSIDE THE PATIENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING SAME PROCEDURE AND THE CUSTOMER MOVED ON TO ANOTHER MCS INSTRUMENT TO CONTINUE THE PROCEDURE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INQUIRED IF THE MCS TIP COVER ACCESSORY WAS CORRECTLY INSTALLED, BUT THE CUSTOMER WAS NOT ABLE TO VERIFY.
cause not established2955842-2023-21603Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-12FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2024-10083da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2024-10083Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-11FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2023-21970da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2023-21970Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-08FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2024-00005ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM.
cause not established3004142400-2024-00005Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2023-12-07FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2024-20289da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A STUDY WHICH COMPARED ROBOT-ASSISTED VERSUS LAPAROSCOPIC LYMPH NODE DISSECTION PROCEDURES IN PATIENTS WITH GYNECOLOGIC MALIGNANCIES, WAS SUMMARIZED IN A LITERATURE ARTICLE. THE ARTICLE COMPARES THE SURGICAL OUTCOMES AND COMPLICATIONS FOR PELVIC LYMPH NODE DISSECTION (PLND) PERFORMED THROUGH CONVENTIONAL LAPAROSCOPIC SURGERY (CLS) VERSUS ROBOT-ASSISTED SURGERY (RAS) IN PATIENTS WITH GYNECOLOGIC MALIGNANCIES OVER A PERIOD OF APPROXIMATELY EIGHT YEARS. THERE WERE 731 PATIENTS WITH GYNECOLOGIC MALIGNANCIES WHO UNDERWENT TRANSPERITONEAL PLND, INCLUDING 460 AND 271 IN THE CLS AND RAS GROUPS, RESPECTIVELY. THE BLOOD LOSS, AND NUMBER OF RESECTED LYMPH NODES WERE 110 +/- 88 ML, AND 45 +/- 17, RESPECTIVELY, IN THE RAS GROUP AND 89 +/- 78 ML, AND 38 +/- 16, RESPECTIVELY, IN THE CLS GROUP. IT WAS CONSIDERED THAT THE DIFFERENCE IN BLOOD LOSS (APPROXIMATELY 20 ML) WAS WITHIN A CLINICALLY ACCEPTABLE RANGE AND RAS RESULTS IN THE RESECTION OF A GREATER NUMBER OF PELVIC LYMPH NODES. THE RATE OF CLAVIEN-DINDO GRADE >/= III COMPLICATIONS WAS 6.3% AND 8.7% IN THE RAS AND CLS GROUPS, RESPECTIVELY. ONE PATIENT IN THE RAS GROUP, COMPARED WITH 4 IN THE CLS GROUP, HAD AN INTRAOPERATIVE VASCULAR COMPLICATIO
cause not established2955842-2024-20289Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-06FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2024-13483da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI-ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY FOLLOWED BY A NON-ROBOTIC IMMEDIATE BREAST RECONSTRUCTION. IT WAS REPORTED THAT THE PATIENT'S LEFT BREAST SHOWED ERYTHEMA AND SWELLING APPROXIMATE THREE MONTHS LATER, AND EXTENDED TO THE ENTIRE BREAST IN A PATCHY PATTERN. THE PATIENT WAS PLACED ON A TRIPLE IV ANTIBIOTIC REGIMEN AND THE LEFT BREAST ERYTHEMA WAS NOTED TO HAVE IMPROVED. THERE WAS NO MENTION OF MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE PROCEDURE.
cause not established2955842-2024-13483Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-05FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2024-10891da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HEPATECTOMY SURGICAL PROCEDURE, THE SLEEVE ON THE JOINT CAME OFF A SYNCHROSEAL INSTRUMENT AND FELL INSIDE THE PATIENT. THE SLEEVE JOINT WAS RETRIEVED INTRAOPERATIVELY DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS WERE AVAILABLE REGARDING THE REPORTED EVENT.
cause not established2955842-2024-10891Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-04FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2023-21678da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY W/ LYMPHADENECTOMY SURGICAL PROCEDURE, USING AN DA VINCI SINGLE PORT SYSTEM, APPROXIMATELY 10 MINUTES AFTER INITIALIZATION, THE SYSTEM DISPLAYED RECOVERABLE ERROR CODE 307 ON PATIENT SIDE MANIPULATOR (PSM) 2. TROUBLESHOOTING WAS PERFORMED. THE SYSTEM WAS RESTARTED, AND A DISABLED ARM PROMPT WAS DISPLAYED. FURTHER TROUBLESHOOTING THROUGH A HARD SYSTEM POWER CYCLE CLEARED THE SYSTEM PROMPT; HOWEVER, WITHIN 1 MINUTE, THE ERROR APPEARED AGAIN. THE SURGEON ELECTED TO CONVERT TO FROM DA VINCI SINGLE PORT SYSTEM TO THE MULTI-PORTS SYSTEM. THERE WAS NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM OPERATED NORMALLY AFTER INITIALIZATION.
cause not established2955842-2023-21678Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-04FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2024-15579da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL SURGICAL PROCEDURE, SP SYSTEM HAD A UNCOVERABLE FAULT ASSOCIATED WITH THIRD INSTRUMENT DRIVE. THE SURGEON DESCRIBED THE EVENT AS THE INSTRUMENT ¿FREEZING¿. THE SURGEON CONVERTED TO DV XI TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED PRIOR TO START OF PROCEDURE. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING UP AND IT INITIALLY DID POWER ON WITHOUT ERRORS. THE TROUBLESHOOTING WAS NOT COMPLETED, AND IT WAS A NON-RECOVERABLE FAULT THAT REQUIRED A FIELD TECH TO COME OUT. PATIENT WAS ALREADY UNDER ANESTHESIA, SO THE XI SYSTEM WAS BROUGHT IN TO CONTINUE. THE PROCEDURE WAS ROBOTICALLY COMPLETED WITH THE XI SYSTEM. ADDITIONAL PORTS WERE PLACED TO COMPLETE THE PROCEDURE. THE PATIENT DID TOLERATE THE CHANGE AND NO PATIENT INJURY OCCURRED.
cause not established2955842-2024-15579Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-12-04FDA MAUDEAuris HealthMonarch Platform3014447948-2023-00032Monarch Platform
Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED DURING A MONARCH BRONCHOSCOPY PROCEDURE AN E-STOP ERROR OCCURRED. THE PHYSICIAN WAS UNABLE TO CLEAR THE E-STOP ERROR AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.
cause not established3014447948-2023-00032Auris HealthMonarch PlatformRead the record ↗Not graded by the source2023-12-01FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2024-11049da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, PHYSICAL DAMAGE WAS OBSERVED ON THE HARMONIC ACE INSTRUMENT. THE INITIAL REPORTER INDICATED THAT THE INSTRUMENT HAD AN "INTERRUPTED TOOTH" AND A FRAGMENT FELL FROM THE INSTRUMENT FELL INSIDE THE PATIENT. THE INITIAL REPORTER ALSO INDICATED THAT THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY USING A BACKUP HARMONIC ACE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORT INDICATED THAT NO DEVICE LANDED INSIDE THE PATIENT; HOWEVER, A FRAGMENT WAS REMOVED ENDOSCOPICALLY. THERE WERE NO REPORTED COMPLICATIONS.
cause not established2955842-2024-11049Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-11-30FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2024-17057da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY (NSM) PROCEDURE FOR THE PATIENT'S RIGHT BREAST CANCER AND LEFT BREAST PROPHYLACTICALLY, THE PATIENT EXPERIENCED POST-OPERATIVE HYPOTENSION PRIOR TO DISCHARGE THAT REQUIRED A BLOOD TRANSFUSION. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT ANY DEVICE MALFUNCTIONS REPORTED. THE INTRA-OPERATIVE BLOOD LOSS WAS REPORTED AS 170ML BUT WAS NOT AN UNEXPECTED VOLUME FOR THE TYPE OF PROCEDURE. NO MEDICAL OR SURGICAL INTERVENTION WAS RENDERED TO STOP THE BLEEDING. ON THE NIGHT OF THE PROCEDURE, THE PATIENT WAS NOTED TO BE HYPOTENSIVE. ON POST-OPERATIVE DAY #2, LAB RESULTS INDICATED A HEMOGLOBIN LEVEL OF 6.6. ONE UNIT OF PACKED RED BLOOD CELLS (PRBC) WAS TRANSFUSED THE NEXT DAY AND THE HYPOTENSION WAS RESOLVED WITH A HEMOGLOBIN LEVEL OF 8.8. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY #3. THE SURGEON BELIEVED THE CAUSE OF THE HYPOTENSION WAS DUE TO INTRA-OPERATIVE BLOOD LOSS AND HEMODILUTION. THREE MONTHS LATER, THE PATIENT WAS FOUND TO HAVE A RIGHT AXILLARY MASS. AN EXCISION OF THE MASS AND A REVISION OF THE BILATERAL BREAST RECONSTRUCTION WAS PERFORMED ON (B)(6) 2024. THE CAUSE OF THE MASS IS UNKNOWN AT
cause not established2955842-2024-17057Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-11-29FDA MAUDEAuris HealthMonarch Platform3014447948-2023-00033Monarch Platform
Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A SUCCESSFUL DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, THE PATIENT DEVELOPED A PNEUMOTHORAX AND LATER PASSED AWAY. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT. PER THE ACCOUNT MANAGER, HOSPITAL ENDO MANAGEMENT DOES NOT ATTRIBUTE THE PNEUMOTHORAX OR THE SUBSEQUENT DEATH TO ANY DEFICIENCY OF THE MONARCH SYSTEM.
cause not established3014447948-2023-00033Auris HealthMonarch PlatformRead the record ↗Not graded by the source2023-11-29FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2024-00534ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INFORMED THAT ONE CASE OF L1-L4 MIS FIXATION WITH INTRAOP (O-ARM)WORKFLOW WAS BEING DONE AND THE PLANNING WAS DONE AFTER REGISTRATION. SURGEON HAD ALREADY PLACED L1 LEFT, L2 LEFT & L3 LEFT SCREWS. AFTER DRILLING IN L4 LEFT PEDICLE, SURGEON HAS CHECKED WITH BALL TIP PROBE AND OBSERVED THAT SOMETHING WAS WRONG, AND HE STOPPED THE PROCEDURE. AFTER CHECKING WITH C-ARM SHOT IT WAS FOUND THAT ALL THREE PLACED SCREWS ARE NOT AS PER THE PLAN AND ALL THE SCREWS WERE SHIFTED MEDIALLY AND CAUDALLY. AFTER THAT SURGEON HAS STOPPED USING ROBOT AND REPOSITIONED ALL THE SCREWS MANUALLY.
cause not established3004142400-2024-00534Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2023-11-29FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2023-21618da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE. THE CUSTOMER USED THE SAME INSTRUMENT TO COMPLETE THE PROCEDURE. FRAGMENTS WERE REPORTED TO FALL INSIDE THE PATIENT AND WERE RETRIEVED FROM THE BODY DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.
cause not established2955842-2023-21618Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-11-29FDA MAUDEZimmer Biomet3009185973-2023-00023ROSA Robotic Surgery
ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED AFTER ROSA SURGERY FOR LASER REMOVAL OF LESION ON RIGHT HIPPOCAMPUS TAIL, PATIENT WAS HAVING STROKE LIKE SYMPTOMS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
cause not established3009185973-2023-00023Zimmer BiometRead the record ↗Not graded by the source2023-11-29FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2024-00251ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND. THIS EVENT OCCURRED IN GERMANY.
cause not established3004142400-2024-00251Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2023-11-29FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2023-21497da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED VIA A SOCIAL MEDIA POSTING THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INNER SILICONE PORTION OF A UNIVERSAL SEAL (5-12MM) BROKE OFF. THE INITIAL REPORTER INDICATED THAT IT SEEMS THAT WHEN CERTAIN INSTRUMENTS ARE INSERTED, A PIECE WOULD RIP OFF AND END UP INSIDE THE PATIENT.
cause not established2955842-2023-21497Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-11-28FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2023-21478da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT WAS LEFT INSIDE THE PATIENT. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE CASE, THE CUSTOMER HABITUALLY INCLUDES THE TIP COVER ACCESSORY IN THE INTRAOPERATIVE COUNTS, BUT DID NOT REALIZE THE COUNT WAS INCORRECT UNTIL AFTER THE PATIENT WAS CLOSED. THE PATIENT REMAINED IN THE OPERATING ROOM AND UNDER ANESTHESIA THROUGHOUT THE EVENT. THE STAFF SPENT ROUGHLY 20 MINUTES SEARCHING THE OR FOR THE MISSING TIP COVER ACCESSORY BEFORE THE SURGEON REOPENED THE PATIENT. A 12MM AND TWO 5MM PORTS WERE USED DURING REENTRY, AND THE TIP COVER ACCESSORY WAS FOUND WITHIN A COUPLE OF MINUTES OF MANIPULATING THE BOWEL. ONCE RETRIEVED, THE CSR INSPECTED THE TIP COVER ACCESSORY AND THERE WAS NO DAMAGE NOTED. ADDITIONALLY, THERE WERE NO ISSUES WITH THE INSTALLATION OF THE TIP COVER ACCESSORY AND NO LUBRICATION WAS USED. DURING THE PROCEDURE, THE CUSTOMER DID NOT EXPERIENCE ANY ISSUES WITH THE INSTRUMENT. THERE WAS NO BULGING OF THE TIP COVER ACCESSORY OBSERVED ON THE MCS INSTRUMENT
cause not established2955842-2023-21478Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-11-23FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2024-00533ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS WAS AN INTRAOP ADOLESCENT SCOLI CASE T4-L5 WITH A SIEMENS CIOS SPIN. WE DIVIDED THE CASE INTO THREE SEGMENTS (L2-L5, T9-T11 AND T4-T6) AND REIMAGED THE PATIENT. APPARENTLY, THE TECHNICIAN CANNOT ISOLATE THE SINGLE SCAN, SO ALL SCANS WERE TRANSFERRED WITH THE LAST ONE. DURING THE NAVIGATION ON THE LAST SEGMENT, THE IMAGE OF THE SCAN WAS KIND OF TORN AND THE SAGITTAL AND AXIAL PLANE LOOKED ALIKE. RESET SOFTWARE, HARD DID NOT HELP, DID A HARD SHUTDOWN AND RESTART. THE ISSUE WITH THE SCAN WAS STILL THERE AND COULD NOT BE SOLVED. THE LAST THREE TRAJECTORIES WERE DRILLED WITH THE ROBOT, BUT SCREWS WERE INSERTED FREEHANDED.
cause not established3004142400-2024-00533Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2023-11-22FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2024-19273da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE. APPROXIMATELY NINE MONTHS LATER, THE PATIENT UNDERWENT A SURGERY FOR INTESTINAL ADHESIONS. ON POST-OPERATIVE DAY THREE, A SMALL AMOUNT OF RED AND WHITE PUS DISCHARGED FROM THE UMBILICAL WOUND WHEN CLEANING WITH SALINE. THE DRESSING WAS SWITCHED TO A WET SALINE DRESSING. ON POST-OPERATIVE DAY SEVEN, THE PATIENT UNDERWENT STOMA SURGERY, WITH A STOMA PLACED IN THE LOWER RIGHT ABDOMEN, A NASOGASTRIC TUBE FOR CONTINUOUS DRAINAGE, AND A RECTAL TUBE FOR CONTINUOUS DRAINAGE OF MODERATE AMOUNTS OF DARK GREENISH-BROWN LIQUID STOOL. ON POST-OPERATIVE DAY EIGHT, A SMALL AMOUNT OF BROWNISH EXUDATE WAS FOUND FROM THE UMBILICAL WOUND. ON THE FOLLOWING DAY, A SAMPLE OF THE BROWNISH EXUDATE FROM THE UMBILICAL WOUND WAS TAKEN FOR CULTURE, AND ANTIBIOTICS WERE ADMINISTERED. ON POST-OPERATIVE DAY 10, THE RECTAL AND NASOGASTRIC TUBES REMOVED. THE ABDOMINAL DISTENSION IMPROVED SIGNIFICANTLY, AND THE DISCOMFORT WAS REDUCED. THE CLEAR LIQUID DIET WAS WELL-TOLERATED. ON POST-OPERATIVE DAY 11, THE UMBILICAL WOUND HAD BROWNISH EXUDATE. THE SUTURES WERE REMOVED, AND POVIDONE-IODINE WAS USED TO PACK T
cause not established2955842-2024-19273Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-11-22FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2023-21297da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2023-21297Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-11-22FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2023-21615da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE TIP FELL OFF FROM THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SP MCS INSTRUMENT AND THE SP MCS TIP ACCESSORY WERE INSPECTED PRIOR TO USE WITH NO DAMAGE NOTED. DURING THE PROCEDURE, THE PLASTIC PART OF THE SP MCS INSTRUMENT WAS BROKEN WHILE DISSECTING THE TISSUE. THIS PLASTIC PART AND THE SP MCS TIP ACCESSORY FELL INSIDE THE PATIENT AND WERE RETRIEVED DURING SAME PROCEDURE. POST-OPERATIVE TESTS WERE NOT PERFORMED AS RETRIEVAL OF THE BROKEN PIECES WAS CONFIRMED WITH VISUAL INSPECTION. IN ADDITION, THE SP MCS INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS AND THE SP MCS TIP ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING USE. THERE WAS NO DIFFICULTY IN REMOVING THE INSTRUMENT AND SP MCS TIP ACCESSORY AND THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE CUSTOMER INDICATED THAT NO DAMAGE, TEARS OR HOLE FOUND ON THE SP MCS TI
cause not established2955842-2023-21615Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-11-20FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2024-00532ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: GPS UNIT IS HAVING HARD DRIVE ISSUES. IT WILL ONLY DISPLAY A BLACK SCREEN WHEN BOOTING UP STATING "REBOOT AND SELECT PROPER BOOT DEVICE OR INSERT BOOT MEDIA IN SELECTED BOOT DEVICE AND PRESS A KEY."
cause not established3004142400-2024-00532Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2023-11-18FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2023-20386da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ACCORDING TO A NEWSPAPER ARTICLE, A PATIENT WHO UNDERWENT A DA VINCI ASSISTED COMPONENT SEPARATION PROCEDURE DEVELOPED A SERIOUS COMPLICATION THAT NECESSITATED AN ADDITIONAL SURGERY. ACCORDING TO THE SURGEON, IT WAS HIS FIRST DA VINCI ASSISTED COMPONENT SEPARATION PROCEDURE THAT HE HAD PERFORMED. THERE WERE NO MALFUNCTIONS OF DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES REPORTED IN THE ARTICLE.
cause not established2955842-2023-20386Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-11-18FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2023-20389da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ACCORDING TO A NEWSPAPER ARTICLE, THERE WAS A DA VINCI-ASSISTED COMPONENT SEPARATION SURGERY THAT HAD POST-OPERATIVE COMPLICATION WHICH REQUIRED AN ADDITIONAL SURGERY. IT WAS REPORTED THAT THE PATIENT DEVELOPED A "MICKEY MOUSE HERNIA", WHERE THE PATIENT'S INTESTINES WERE BULGING OUT OF HER SIDES. THE SURGEON THAT PERFORMED THE REPAIR BELIEVED THE PROCEDURE WAS DONE INCORRECTLY AND THAT THAT THE ORIGINAL SURGEON HAD CUT INTO THE WRONG MUSCLE PLANE. THERE WERE NO MALFUNCTIONS OF DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES REPORTED IN ANY OF THE PROCEDURES IN THE ARTICLE.
cause not established2955842-2023-20389Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-11-17FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2024-00223ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00223Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2023-11-16FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2023-21211da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2023-21211Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2023-11-15FDA MAUDEMedtronic plc — Surgical RoboticsMazor X3005075696-2023-00061Mazor X
Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FARIVAR, D., KIM, T. T., SY, C. A., BARON, E. M., NOMOTO, E. K., WALKER, C. T., & AMP; SKAGGS, D. L. (2023). COMPLICATIONS HAVE NOT IMPROVED WITH NEWER GENERATION ROBOTS. GLOBAL SPINE JOURNAL. HTTPS://DOI.ORG/10.1177/21925682231216081 OBJECTIVE: THE PURPOSE OF THIS STUDY WAS TO SEE WHETHER UPGRADES IN NEWER GENERATION ROBOTS IMPROVE SAFETY AND CLINICAL OUTCOMES FOLLOWING SPINE SURGERY. METHODS: ALL PATIENTS UNDERGOING ROBOTIC-ASSISTED SPINE SURGERY WITH THE MAZOR X STEALTH EDITIONTM (MEDTRONIC, MINNEAPOLIS, MN) FROM 2019 TO 2022 AT A COMBINED ORTHOPEDIC AND NEUROSURGICAL SPINE SERVICE WERE RETROSPECTIVELY REVIEWED. ROBOT RELATED COMPLICATIONS WERE RECORDED. RESULTS: 264 CONSECUTIVE PATIENTS (54.1% FEMALE; AGE AT TIME OF SURGERY 63.5 ± 15.3 YEARS) OPERATED ON BY 14 SURGEONS WERE ANALYZED. THE AVERAGE NUMBER OF INSTRUMENTED LEVELS WITH ROBOTICS WAS 4.2 ± 2.7, WHILE THE AVERAGE NUMBER OF INSTRUMENTED SCREWS WITH ROBOTICS WAS 8.3 ± 5.3. THERE WAS A NEARLY 50/50 SPLIT BETWEEN AN OPEN AND MINIMALLY INVASIVE APPROACH. SIX PATIENTS (2.2%) HAD ROBOT RELATED COMPLICATIONS. THREE PATIENTS HAD TEMPORARY NERVE ROOT INJURIES FROM MISPLACED SCREWS THAT REQUIRED REOPERATION, ONE PATIENT HAD A PERM
cause not established3005075696-2023-00061Medtronic plc — Surgical RoboticsMazor XRead the record ↗Not graded by the source2023-11-15FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2024-00528ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CASE WAS AN L4-S1 ALIF 360 USING HEDRON IA AND CREO ONE HARDWARE. THERE WAS NO PRIOR HARDWARE IN THE PATIENT. THE EGPS WORKFLOW WAS INTRA-OP CT. THE EGPS IS RUNNING SOFTWARE VERSION 1_1R3. THE PATIENT WAS POSITIONED PRONE FOR THE POSTERIOR PORTION AND THE CAMERA WAS POSITIONED AT THE FOOT OF THE BED. AN O-ARM WAS USED FOR IMAGING AND REGISTRATION. DR. (B)(6) PLACED THE DRB AT RIGHT PSIS WITH THE LOW-PROFILE QUATTRO SPIKE AND SURVEILLANCE MARKER AT LEFT PSIS. SURVEILLANCE WAS REGISTERED PRIOR TO THE ICT BEING POSITIONED ON THE QUATTRO SPIKE. THE ICT WAS POSITIONED, THE BED WAS RAISED, AND THE SURGICAL SNAPSHOT WAS TAKEN. THE O-ARM SPIN WAS ACQUIRED AND TRANSFERRED SUCCESSFULLY TO EGPS VIA ETHERNET. ALL 7 FIDUCIALS WERE CAPTURED SUCCESSFULLY, AND THE REGISTRATION FIT WAS DOWN ON GREEN. DR. (B)(6) PERFORMED LANDMARK CHECKS ON THE ICT FIDUCIALS AS WELL AS DOWN THE LOW-PROFILE QUATTRO SPIKE. NAVIGATION APPEARED TO EVERYONE IN THE ROOM TO BE ACCEPTABLE AND OF HIGH QUALITY. FOLLOWING PERCUTANEOUS PLACEMENT OF ALL SCREWS THROUGH BILATERAL WILTSY INCISIONS, A POST-OP REGISTRATION O-ARM SPIN WAS ACQUIRED. DR. (B)(6) DECIDED TO DO THIS PRIOR TO LOCKING THE CONSTRUCT DOWN AS HE QUESTIONED
cause not established3004142400-2024-00528Globus MedicalExcelsiusGPSRead the record ↗