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 H11 FOR FOLLOW-UP INFORMATION.

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 H11 FOR FOLLOW-UP INFORMATION.

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 MEDIASTINAL TUMOR RESECTION PROCEDURE, FRAGMENTS FROM THE SYNCHROSEAL INSTRUMENT FELL OUT INTO THE PATIENT. THE MEDICAL DIRECTOR AND PRIMARY SURGEON FOR THE CASE STATED THAT IT WAS UNCLEAR WHEN THE DEVICE FRAGMENT FELL INTO THE PATIENT DURING THE PROCEDURE. THE SURGEON STATED THAT THE FRAGMENT WAS RETRIEVED BY REMOVING THE SYNCHROSEAL, UNDOCKING THE SYSTEM, AND USING VATS FORCEPS TO EXTRACT THE PART; THIS WAS CONFIRMED VISUALLY. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED, AND AN X-RAY EXAMINATION WAS PERFORMED POST-OPERATIVELY TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACKUP VESSEL SEALER EXTEND WITH NO INJURY TO THE PATIENT.

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 THAT THE PATIENT PRESENTED 3 WEEKS OR 3 MONTHS POST-OP WITH A FRACTURED FEMUR AT THE LOCATION WHERE THE FEMORAL REFERENCE PINS WERE INSTALLED. ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED TO CORRECT THE FRACTURE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

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 H11 FOR FOLLOW-UP INFORMATION.

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 TIP BROKE ON THE HARMONIC ACE INSTRUMENT AND A FRAGMENT FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO INJURY TO THE PATIENT. THERE IS NO FURTHER INFORMATION AVAILABLE.

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 DURING THE MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN WAS PERFORMING THE BRONCHOALVEOLAR LAVAGE (BAL) WHEN THE PATIENT HAD A CARDIAC ARREST. THE PHYSICIAN WAS ABLE TO CONFIRM A PULSE BACK ON THE PATIENT. THE PATIENT IS IN STABLE CONDITION.

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 REVIEW OF AN ARTICLE THAT COMPARED SALVAGE ROBOTIC RADICAL PROSTATECTOMY (SRRP) FOR RECURRENT PROSTATE CANCER (PCA) AFTER PRIMARY RADIATION (RT) VERSUS FOCAL THERAPY (FT). WAS PERFORMED. THE STUDY ANALYZED 112 PATIENTS UNDERGOING SALVAGE ROBOTIC RADICAL PROSTATECTOMY BETWEEN JANUARY 2010 AND DECEMBER 2022. A TOTAL OF 31 PATIENTS EXPERIENCED COMPLICATIONS, INCLUDING BLADDER NECK CONTRACTURE, LYMPHOCELE, RECTAL INJURY REQUIRING INTRAOPERATIVE REPAIR, URINE LEAK, HEMATURIA, ACUTE URINARY RETENTION, DEEP VEIN THROMBOSIS, URINARY TRACT INFECTION, AND SURGICAL SITE INFECTION. THE ARTICLE ADDITIONALLY REPORTED LOW HEMOGLOBIN REQUIRING TRANSFUSION. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY ISI DEVICE. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT SCREWS WERE CORRECTLY PLACED AT L4 AND S1. HOWEVER, BOTH SCREWS PLACED AT L5 (LEFT AND RIGHT) WERE POSITIONED MORE SUPERIOR AND LATERAL THAN THE PLANNED TRAJECTORY. IT WAS SUSPECTED THAT THE SCREWS HAD ENTERED THE DISC SPACE, PROMPTING THE SURGEON TO DECIDE ON THEIR REMOVAL. IT WAS ALSO NOTED THAT THE PATIENT HAD SMALL PEDICLES AT L5. AS THE SURGEON ATTEMPTED TO REMOVE THE RIGHT L5 SCREW, THE SCREW WAS INADVERTENTLY PUSHED FURTHER IN, POTENTIALLY DEEPER INTO THE DISC SPACE. THE PATIENT BEGAN TO EXPERIENCE INTERNAL BLEEDING FROM AN UNKNOWN SOURCE. THE SURGICAL TEAM FLIPPED THE PATIENT OVER AND BEGAN EFFORTS TO STABILIZE THEM. APPROXIMATELY FIVE MINUTES AFTER SCREW REMOVAL AT L5, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP, AND THE TEAM CONTINUED WORKING TO STABILIZE THE PATIENT. ULTIMATELY, SCREWS WERE PLACED AT L4 AND S1, WHILE L5 WAS SKIPPED. A ROD WAS PLACED, RESULTING IN APPROXIMATELY A ONE-HOUR DELAY TO THE CASE. ADDITIONAL INFORMATION WAS RECEIVED. TRAJECTORIES WERE DEVIATED BETWEEN 3.5 AND 10 MILLIMETERS (MM).

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 NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE AND WAS DISCHARGED THE NEXT DAY. ON THE 14-DAY FOLLOW-UP VISIT, SEROMA WAS IDENTIFIED AND SUBSEQUENTLY ASPIRATED. AT THE PATIENT'S 42-DAY FOLLOW-UP THE SEROMA HAD COME BACK AND A DRAIN WAS PLACED TWO WEEKS LATER. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MILD SEVERITY, A CLAVIEN-DINDO GRADE III, NOT RELATED TO A DA VINCI DEVICE, NOT RELATED TO THE PATIENT'S PRE-EXISTING CONDITION, BUT POSSIBLY RELATED TO THE SP NSM PROCEDURE AND POSSIBLY RELATED TO THE RECONSTRUCTION PROCEDURE.

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 REVIEW OF A LITERATURE ARTICLE, "SINGLE-PORT ROBOT-ASSISTED MINIMALLY INVASIVE ESOPHAGECTOMY USING THE SINGLE-PORT ROBOTIC SYSTEM VIA THE SUBCOSTAL APPROACH: A SINGLE-CENTER RETROSPECTIVE STUDY" WAS PERFORMED. THIS WAS A RETROSPECTIVE STUDY OF 53 PATIENTS WHO UNDERWENT MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) AT A SINGLE CENTER BETWEEN FEBRUARY 2017 AND DECEMBER 2024. PATIENTS UNDERWENT HYBRID LAPAROSCOPIC ROBOT-ASSISTED MINIMALLY INVASIVE ESOPHAGECTOMY (RAMIE), COMPRISING A ROBOTIC THORACIC PHASE AND LAPAROSCOPIC ABDOMINAL PHASE, WITH OR WITHOUT AN OPEN CERVICAL PHASE. THE ARTICLE NOTED THAT ONE 57-YEAR-OLD MALE PATIENT WHO UNDERWENT A DA VINCI SINGLE-PORT (SP) SURGERY REQUIRED REOPERATION OWING TO ANASTOMOTIC LEAKAGE FOLLOWING THE MCKEOWN PROCEDURE. THIS PATIENT ALSO HAD VOCAL CORD PALSY AND PNEUMONIA. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. STUDY LIMITATIONS INCLUDED: ALL THORACIC AND CERVICAL PROCEDURES WERE PERFORMED BY ONE THORACIC SURGEON, WHILE ALL ABDOMINAL PROCEDURES WERE PERFORMED BY ONE UPPER GASTROINTESTINAL SURGEON AT A SINGLE CENTER; THIS W

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 TIP OF THE HARMONIC ACE INSTRUMENT BROKE WHILE THE SURGEON WAS DISSECTING AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED DURING THE SAME PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT, NOR WERE ANY POST-OPERATIVE TESTS, SUCH AS X-RAY OR ULTRASOUND, PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACK-UP HARMONIC ACE INSTRUMENT. THERE WERE NO POST-SURGICAL COMPLICATIONS REPORTED.

Aiper Seagull Pro Cordless Robotic Pool Vacuum Cleaners Recalled Due to Burn and Fire Hazards; Distributed by Shenzhen Aiper Intelligent Co. — Hazard: The recalled pool vacuum cleaner has a large current adapter that can overheat, posing burn and fire hazards. Reported incidents: The firm has received 19 reports of the recalled pool vacuums melting, smoking or catching on fire while charging causing five incidents of property damage. No injuries have been reported.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THROUGH A MEDWATCH RECEIVED FROM THE FDA ALLEDGING OCCURANCES OF INACCURATE CUTS AND INCORRECT PLACEMENT OF IMPLANTS RESULTING IN PATIENT INJURIES. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

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 NEUTRAL GROUNDING PAD WAS NOT RECOGNIZED BY THE ENERGY SHIELD MONITOR (ESM). BEFORE CONTACTING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER ATTEMPTED TO RESOLVE THE ISSUE BY REPLACING THE NEUTRAL PAD, BUT THE PROBLEM PERSISTED. THE CUSTOMER ALSO CONNECTED THE NEUTRAL PAD DIRECTLY TO THE ERBE GENERATOR, WHERE THE ICON APPEARED GREEN. THE TSE THEN INSTRUCTED THE CUSTOMER TO RESEAT BOTH THE INSTRUMENT AND THE NEUTRAL CABLE ON THE ESM; HOWEVER, THE ISSUE CONTINUED. THE TSE FURTHER ADVISED ATTACHING THE NEUTRAL PAD TO THE CUSTOMER¿S ARM TO CHECK ITS STATUS, BUT THE FAULT REMAINED. FINALLY, THE TSE GUIDED THE CUSTOMER THROUGH A COMPLETE POWER CYCLE OF THE ESM, YET THE ERROR PERSISTED. AS A RESULT, THE PROCEDURE WAS ABORTED AFTER ANESTHESIA WAS ADMINISTERED AND PORTS HAD BEEN PLACED.

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 H11 FOR FOLLOW-UP INFORMATION.

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 THE PHYSICIAN USED EBUS TO TARGET THE RIGHT UPPER LOBE (RUL). THE PHYSICIAN NOTICED THROUGH HIS MANUAL SCOPE THAT THERE WAS A SMALL LACERATION ON THE MUCOSA OF THE POST INTERIOR WALL OF THE RIGHT MAIN STEM. THE PHYSICIAN WAS NOT SURE HOW THIS OCCURRED. THE PHYSICIAN DECIDED TO ABORT THE CASE BECAUSE THEY DID NOT WANT TO CAUSE ANY FURTHER INJURY. THE PATIENT DID NOT EXPERIENCE ANY BLEEDING UPON WAKING UP. NOTABLY, THE ANESTHESIOLOGIST SUGGESTED THAT THE PATIENT MAY HAVE HAD FRAIL TISSUE, AND THE PHYSICIAN RECALLED A SIMILAR INCIDENT FROM TWO YEARS PRIOR IN THE SAME LOCATION, WHICH HAD RESOLVED WITHOUT COMPLICATIONS.

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 H11 FOR FOLLOW-UP INFORMATION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

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 H11 FOR FOLLOW-UP INFORMATION.

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 MONOPOLAR CURVED SCISSORS (MCS) TIP INSTALLED ON AN MCS INSTRUMENT, CAME OFF AND FELL INSIDE THE PATIENT'S BODY. THE CUSTOMER RETRIEVED THE MCS TIP AND TRIED TO PUT IT BACK ON THE MCS INSTRUMENT; HOWEVER, IT DID NOT WORK FOR AN UNSPECIFIED REASON. THEREFORE, THE CUSTOMER REPLACED THE MCS TIP. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT WAS INSPECTED PRIOR TO USE AND NOTHING ABNORMAL WAS NOTED. IT IS UNKNOWN WHAT TASK WAS BE BEING PERFORMED AT THE TIME OF THE EVENT. THE SURGEON STATED THAT THE TIP OF THE MCS INSTRUMENT HAD BECOME STUCK IN THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT AND THEN IT WAS FORCIBLY REMOVED, WHICH WAS THE CAUSE OF THE MCS TIP INSIDE THE PATIENT. IT IS UNKNOWN FOR HOW LONG THE INSTRUMENT WAS IN USE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT PRIOR TO THE VENT. THE SURGEON DID NOT FEEL ANY RESISTANCE UPON FINAL REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. ADDITIONALLY, THE SURGICAL STAFF DID NOT SEE ANY DAMAGE

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 H11 FOR FOLLOW-UP INFORMATION.

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, AN INTERNAL COLLISION CAUSED THE O-RING/WASHER TO DISLODGE WHILE THE INSTRUMENT WAS IN THE PATIENT. THE O-RING WAS LOCATED AND REMOVED ALONG WITH THE DEFECTIVE INSTRUMENT AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT.

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 RIGHT UPPER PULMONARY LOBECTOMY PROCEDURE, BLEEDING OCCURRED UPON REMOVAL OF THE SYNCHROSEAL INSTRUMENT FROM THE PATIENT. AT THE POINT OF VASCULAR DETACHMENT, DURING THE SEALING AND CUTTING PROCESS, THE SURGEON WAS UNABLE TO PROPERLY GRASP THE PENROSE DRAIN AT THE BACK OF THE BLOOD VESSEL. THE SURGEON STATED THAT THE SYNCHROSEAL INSTRUMENT SUCCESSFULLY SEALED AND CUT. THE SURGEON ALSO CONFIRMED THAT THE APPROPRIATE SEALING TONES WERE HEARD. HOWEVER, UPON WITHDRAWING THE SYNCHROSEAL INSTRUMENT FOR REINSERTION, BLEEDING OCCURRED FROM THE PULMONARY ARTERY (PA), LOCATED BENEATH THE INTENDED VESSEL THAT WAS SEALED AND CUT. ALTHOUGH THE EXACT VOLUME OF BLEEDING IS UNKNOWN, THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION. THE BLEEDING WAS CONTROLLED THROUGH THE ASSISTANT'S PORT BY APPLYING COMPRESSION TO THE SITE, AND THE SURGICAL APPROACH WAS CONVERTED TO AN OPEN THORACOTOMY. WHILE THE SURGEON WAS CHECKING THE FIELD OF VIEW, THE SURGEON BELIEVES THAT THE WRIST OF THE SYNCHROSEAL INSTRUMENT INADVERTENTLY MADE CONTACT WITH THE PA, CAUSING THE VESSEL TO RUPTURE. THE PROCEDURE WAS COMPLETED AND THE PATIENT REQUIRED AN ADDITIONAL 2-3 DAYS OF HOS

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 THYROIDECTOMY PROCEDURE, THE PLASTIC TIP OF THE HARMONIC ACE INSTRUMENT TIP FELL OFF. A NURSE STATED THAT THE SURGEON WAS DISSECTING WHEN THE FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE AND IT WAS CONFIRMED WITH VISUAL CONFIRMATION. NO ADDITIONAL SURGICAL PROCEDURE WERE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. A BACK-UP HARMONIC ACE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS.

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, AN HOUR AND A HALF AFTER THE START OF THE PROCEDURE, WHILE THE INSTRUMENT WAS INSIDE THE PATIENT¿S ANATOMY, IT WAS DISCOVERED THAT THE WHITE PART OF THE TIP SEAL OF THE SYNCHROSEAL INSTRUMENT WAS DAMAGED. USE OF THE INSTRUMENT WAS DISCONTINUED, AND IT WAS REPLACED TO THE BACKUP. THE TIP WAS SPREAD WITH THE DA VINCI INSTRUMENT, AND THE DAMAGED LOCATION WAS MATCHED WITH THE FRAGMENT TO CONFIRM THAT THERE WAS NO MISSING MATERIAL RETAINED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO THE RETENTION OF FOREIGN MATERIAL. THE USER COMPLETED THE PROCEDURE.

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 H11 FOR FOLLOW-UP INFORMATION.

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 DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED DIFFICULTY NAVIGATING AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 PANCREATICODUODENECTOMY SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE WAS DAMAGED DURING THE OPERATION. THE FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.

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 MALIGNANT HYSTERECTOMY PROCEDURE, A PORTION OF THE BLACK RUBBER OF A UNIVERSAL SEAL BROKE OFF AND FELL INSIDE THE PATIENT. A BLACK FOREIGN BODY PARTICLE WAS FOUND IN PATIENT'S PELVIS. THE BLACK PARTICLE WAS REMOVED AND THE PATIENT'S PELVIS WAS RE-EXAMINED TO ENSURE ALL FOREIGN BODIES WERE REMOVED FROM PATIENT. NO OTHER FRAGMENTS WERE FOUND INSIDE THE PATIENT. ONCE PARTICLE WAS OUTSIDE OF PATIENT. THE FRAGMENT WAS EXAMINED BY A TEAM MEMBER AND IT WAS CONFIRMED THAT THE PARTICLE CAME OFF OF A UNIVERSAL SEAL.

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 AND ADJUSTED INTRA-OPERATIVELY.

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 THE BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED MEDIASTINAL EMPHYSEMA, AS INDICATED BY THE POSTOPERATIVE CT EXAMINATION. AFTER A FOLLOW-UP CT SCAN DEMONSTRATED RECOVERY, THE PATIENT WAS DISCHARGED ON (B)(6), FOLLOWING A TOTAL HOSPITAL STAY OF 6 DAYS.

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 DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 SURGICAL PROCEDURE, THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) SCAN ONE YEAR AFTER THE SURGERY AND AN OBJECT WAS IDENTIFIED, THEY HAD THE SIZE AND SHAPE OF THE OBJECT AND CONFIDENT IT IS THE REPLACEMENT TOOL FOR THE MONOPOLAR CURVED SHEARS INSULATION, THE SILICONE APPLICATOR, AND THEY BELIEVE SOMEBODY LEFT IT ON WHEN THEY PLACED IT THROUGH A 12 MM PORT AND THEIR ASSUMPTION IS IT FELL OFF WITHIN THE PATIENT. THE PROCEDURE WAS COMPLETED. NO INTERVENTION WAS NOTED, AND THE PATIENT WAS REPORTEDLY DOING FINE AND ASYMPTOMATIC. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE RETAINED ITEM WAS NOT THE TIP COVER. RATHER, IT WAS THE CLEAR APPLICATOR TOOL TO APPLY AND REMOVE THE TIP COVER. THE CUSTOMER WAS NOT PLANNING TO RETURN THE APPLIER; IT IS REMAINING INSIDE OF THE PATIENT.

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 TIP ON THE HARMONIC ACE INSTRUMENT WAS BROKEN. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE SURGEON WAS DISSECTING WHEN THE ISSUE OCCURRED. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING PROCEDURE. THE INSTRUMENT IS AVAILABLE FOR REVIEW. NO PHOTOS OR VIDEOS ARE AVAILABLE FOR REVIEW. THE PIECE WAS COMPLETELY BROKEN OFF/MISSING. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE.

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 H11 FOR FOLLOW-UP INFORMATION.

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 CHOLECYSTECTOMY. THE SURGERY WAS PERFORMED SUCCESSFULLY, AND THE PATIENT WAS DISCHARGED THE NEXT DAY. AT HOME, THE PATIENT EXPERIENCED UMBILICAL WOUND PAIN WITH PURULENT DISCHARGE. AFTER EVALUATION, A PLASTIC SURGEON RECOMMENDED DEBRIDEMENT AND WOUND REPAIR. ONE WEEK LATER, THE PATIENT WAS HOSPITALIZED FOR UMBILICAL WOUND REPAIR AND DEBRIDEMENT SURGERY. THERE WAS NO REPORT THAT A DA VINCI DEVICE MALFUNCTIONED DURING THE SURGERY. THE STUDY INVESTIGATOR REPORTED THAT THE EVENT WAS UNLIKELY RELATED TO THE DA VINCI DEVICE AND UNLIKELY RELATED TO THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING INFORMATION. THE SITE CONFIRMED THAT THE EVENT IS RELATED TO A WOUND INFECTION AND AMPICILLIN AND SULBACTAM, CURAM WERE PRESCRIBED. THE PATIENT WAS DISCHARGED WITH NO OTHER COMPLAINTS. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS AND A DA VINCI DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

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 CUSTOMER HAD AN IMAGE ORIENTATION ISSUE. THE CAMERA HAD ROTATED, THE ENTRY GUIDE MANIPULATOR (EGM) REPOSITIONED VERTICALLY, AND THE ISSUE REOCCURRED. NO FURTHER DETAILS WERE AVAILABLE AND THERE WERE NO ERRORS TO INDICATE FAILURE. THE PROCEDURE WAS CONVERTED TO MULTI-PORT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ENDOSCOPE MOVED FREELY WITH UNCONTROLLED MOTION. HOWEVER, THE IMAGE WAS NOT INVERTED. THE EVENT DID NOT INVOLVE A REVERSED CONTROL OF THE SYSTEM ARMS. IT WAS EXPLAINED THAT WHEN TH SURGEON MOVED FORWARD WITH THE SP CAMERA, THE ENTIRE BOOM RELOCATED TO ANOTHER POSITION. THE SURGEON CONFIRMED THAT THE DESIRED ORIENTATION WAS OBTAINED WHEN THE ENDOSCOPE WAS INSTALLED. THE HORIZON WAS REPORTEDLY YELLOW AND DID NOT SHOW THE SURGEON IF HE WAS LEVEL. THE SURGEON ELECTED TO COMPLETE THE CASE VIA A MULTI-PORT SYSTEM.

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 ROBOTIC BRONCHOSCOPY PROCEDURE, THE PATIENT HAD A PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND THE PATIENT WAS MONITORED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS DISCHARGED HOME SIX DAYS AFTER THE PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: STAPLER WAS CLAMPED ONTO STOMACH TISSUE AND FROZE - IT WOULD NOT FIRE, IT WOULD NOT RELEASE. THE EMERGENCY BUTTON WAS PUSHED AND STAPLER REMOVED MANUALLY.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF AN ARTICLE WAS PERFORMED THAT EVALUATED OUTCOMES OF ROBOTIC INGUINAL HERNIA REPAIR (RIHR) IN A SINGLE INSTITUTION STUDY COMPARING SURGEONS WITH VARYING ROBOTIC EXPERIENCE. THE STUDY ANALYZED 297 PATIENTS UNDERGOING ROBOTIC INGUINAL HERNIA REPAIR BETWEEN JULY 2016 AND SEPTEMBER 2021. ONE PATIENT DIED WITHIN 30 DAYS POST SURGERY DUE TO ASPIRATION PNEUMONIA LEADING TO CARDIAC ARREST. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY ISI DEVICE. INTUITIVE SURGICAL INC, (ISI) CONTACTED THE AUTHOR WHO REPORTED THAT THERE WERE NO ISSUES SEEN OR RECORDED WITH THE DA VINCI SYSTEM DURING THE STUDY. THE SYSTEM ITSELF DID NOT CONTRIBUTE TO THE DEATH IN THE STUDY WHICH WAS RELATED TO THE PATIENTS CO MORBIDITY AND NOT THE SURGERY ITSELF.

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 REVIEW OF AN ARTICLE THAT EVALUATED THE OUTCOMES OF ROBOTIC INGUINAL HERNIA REPAIR (RIHR) IN A SINGLE-INSTITUTION STUDY COMPARING SURGEONS WITH VARYING ROBOTIC EXPERIENCE. THE STUDY ANALYZED 297 PATIENTS UNDERGOING ROBOTIC INGUINAL HERNIA REPAIR BETWEEN JULY 2016 AND SEPTEMBER 2021. THERE WERE 6 (2%) INTRAOPERATIVE COMPLICATIONS, INCLUDING 5 (1.7%) SEROSAL TEARS AND 1 (0.3%) FULL THICKNESS ENTEROTOMY. TWO CASES (0.7%) REPORTED CONVERSION TO OPEN PROCEDURES. ONE CASE INVOLVED A CHRONICALLY INCARCERATED SIGMOID COLON THAT COULD NOT BE REDUCED VIA A MINIMALLY INVASIVE APPROACH. THE SECOND CASE INVOLVED A RECURRENT HERNIA WITH SIGNIFICANT ADHESIONS AROUND A PRIOR PLUG REPAIR. ALL INTRAOPERATIVE INJURIES WERE CAUGHT AT THE TIME OF SURGERY AND DID NOT REQUIRE TAKEBACKS OR CAUSE SIGNIFICANT UNDUE HARM TO THE PATIENT. 28 PATIENTS (9.4%) PRESENTED TO THE ED WITH 30 DAYS OF THEIR SURGERIES WITH 20 PATIENTS (6.7%) RECEIVING ABDOMINAL IMAGING AND 13 PATIENTS (4.4%) BEING READMITTED. THERE WERE 8 TOTAL (2.7%) COMPLICATIONS INCLUDING 2 (0.7%) COMPLICATED SEROMAS, 4 HEMATOMAS (1.3%), AND 1 (0.3%) PATIENT WITH URINARY RETENTION. 30 DAY COMPLICATIONS WERE ALSO LARGELY MINOR WITH ONE PATIENT REQUI

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 H11 FOR FOLLOW-UP INFORMATION.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PHYSICIAN(S) PERFORMED A REVISION ON THIS PATIENT AND ALL HARDWARE WAS TO BE REPLACED. THE INFECTION WAS NOTED TO BE OSTEOMYELITIS.

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, THERE WAS A DAMAGED VALVE ON THE CANNULA SEAL ACCESSORY. A FRAGMENT FELL INSIDE OF THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: A FRAGMENT FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE, ALL FRAGMENTS WERE RETRIEVED BY USING LAPAROSCOPIC FORCEPS. A BLACK PIECE WAS FOUND IN THE SURGICAL FIELD, AND UPON CHECKING THE UNIVERSAL SEAL IT WAS FOUND TO BE DAMAGED. THERE WAS NO RAPID LOSS OF INSUFFLATION AS A RESULT OF THE BREAKAGE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DAVINCI XI SHUT DOWN MID PROCEDURE DUE TO OVERHEATING, NO WARNING NOTED DURING OPERATION.

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 H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF THE CLINICAL ARTICLE WAS CONDUCTED, WHICH SUMMARIZED THE CLINICAL EXPERIENCE AND OUTCOMES OF TRANSORAL ROBOTIC SURGERY (TORS) IN THE TREATMENT OF HYPOPHARYNGEAL CARCINOMA. THE RETROSPECTIVE MULTICENTER STUDY ANALYZED 28 PATIENTS (ALL MALE, AGED 47- 82 YEARS) UNDERGOING TRANSORAL ROBOTIC SURGERY USING THE DA VINCI SI OR XI SURGICAL SYSTEM BETWEEN SEPTEMBER 2017 AND MARCH 2024. THE ARTICLE REPORTED TWO POSTOPERATIVE DEATHS WITHIN ONE MONTH OF SURGERY WITHOUT ANY OTHER DETAILS. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DA VINCI SURGICAL SYSTEM. REQUESTS FOR ADDITIONAL INFORMATION WERE MADE TO THE CORRESPONDING AUTHOR, BUT NO RESPONSE HAS BEEN RECEIVED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: SONI, ABHISHEK, ET AL. ¿ROBOT-ASSISTED CERVICAL PEDICLE SCREW PLACEMENT USING A NOVEL HYBRID DILATOR TECHNIQUE: A CLINICAL SERIES OF 565 SCREWS.¿ JOURNAL OF CRANIOVERTEBRAL JUNCTION AND SPINE, VOL. 16, NO. 3, 18 SEPT. 2025, PP. 301¿306, HTTPS://DOI.ORG/1 0.4103/JCVJS.JCVJS_115_25. ABSTRACT BACKGROUND: CERVICAL PEDICLE SCREWS PROVIDE SUPERIOR BIOMECHANICAL FIXATION WITH PULLOUT STRENGTH FOUR TIMES GREATER THAN LATERAL MASS SCREWS, BUT PLACEMENT IS TECHNICALLY DEMANDING WITH TRADITIONAL MALPOSITION RATES OF 6.7%¿31.6%. ROBOTIC-ASSISTED SPINE SURGERY HAS DEMONSTRATED SUCCESS IN THORACOLUMBAR APPLICATIONS, BUT CERVICAL TRANSLATION HAS BEEN HINDERED BY THE LACK OF CERVICAL-SPECIFIC I NSTRUMENTATION REQUIRING EXPENSIVE CUSTOM INSTRUMENTS. METHODS: WE DEVELOPED A HYBRID TECHNIQUE COMBINING ROBOTIC GUIDANCE WITH STANDARD CERVICAL INSTRUMENTATION USING MINIMALLY INVASIVE SURGERY DILATORS AS AN INTERFACE. SIXTY-FIVE CONSECUTIVE PATIENTS UNDERWENT ROBOT-ASSISTED CERVICAL PEDICLE SCREW PLACEMENT WITH 565 SCREWS ACROSS C2¿C7 LEVELS USING MAZORX STEALTH ROBOTIC SYSTEM WITH O-ARM NAVIGATION. ACCURACY WAS ASSESSED USING GERTZBEIN-ROBBINS AND NEO CLASSIFICATION SYSTEMS WITH 3¿6-MONTH FOLL

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 INGUINAL HERNIA SURGICAL PROCEDURE, THE PATIENT'S SKIN WAS SINGED SLIGHTLY AT THE PORT SITE WITH THE MONOPOLAR CURVED SCISSORS (MCS.) THE SINGED SKIN WAS EXCISED MINIMALLY DURING CLOSURE. INSPECTION OF THE TIP COVER ACCESSORY REVEALED NO DEFECTS BY STAFF. NO COLLISIONS OF INSTRUMENTS WERE REPORTED. THE PATIENT IS REPORTEDLY DOING WELL. THE PROCEDURE WAS COMPLETED ROBOTICALLY.