Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE DEVIATION AMOUNT WAS AROUND 3 MILLIMETERS (MM).

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 MERGE ISSUE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: ZHANG, H., DINGJUN, H., BAORONG, H., HONGHUI, S., ZHENGWEI, X., BIAO, W., YONGCHAO, D., WENLONG, Y., ZILIN, G., CHANGJIANG, K. (2024). COMPARISON OF THE ACCURACY AND SAFETY OF ROBOT-AND NAVIGATION-ASSISTED SCREW PLACEMENT IN ATLANTOAXIAL DISLOCATION SURGERY. NATL MED J CHINA, 104(37), 3506¿3512. HTTPS://DOI.ORG/10.3760/CMA.J.CN112137-20240329-00722 OBJECTIVE: TO COMPARE THE ACCURACY AND SAFETY OF ROBOT-ASSISTED AND NAVIGATION-ASSISTED SCREW PLACEMENT IN ATLANTOAXIAL DISLOCATION SURGERY. METHODS: A RETROSPECTIVE ANALYSIS WAS CONDUCTED ON THE CLINICAL DATA OF 49 PATIENTS WITH ATLANTOAXIAL DISLOCATION TREATED CONSECUTIVELY AT THE HONGHUI HOSPITAL OF XI'AN JIAOTONG UNIVERSITY FROM APRIL 2022 TO DECEMBER 2023. AMONG THEM, 27 WERE MALE AND 22 WERE FEMALE, AGED (44.2±11.7) YEARS. BASED ON THE DATE OF SURGERY, 29 PATIENTS (FROM APRIL 2022 TO APRIL 2023) RECEIVED THE S8 NAVIGATION-ASSISTED SCREW PLACEMENT (NAVIGATION GROUP), 20 PATIENTS (FROM MAY TO DECEMBER 2023) RECEIVED MAZOR ROBOT-ASSISTED SCREW PLACEMENT (ROBOT GROUP). THE ACCURACY OF SCREW PLACEMENT, SCREW PLACEMENT TIME, OPERATION TIME, INTRAOPERATIVE BLOOD LOSS, AND INTRAOPERATIVE COMPLICATIONS WERE RECORDED AND COMPARED B

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: ZHANG, H., DINGJUN, H., BAORONG, H., HONGHUI, S., ZHENGWEI, X., BIAO, W., YONGCHAO, D., WENLONG, Y., ZILIN, G., CHANGJIANG, K. (2024). COMPARISON OF THE ACCURACY AND SAFETY OF ROBOT-AND NAVIGATION-ASSISTED SCREW PLACEMENT IN ATLANTOAXIAL DISLOCATION SURGERY. NATL MED J CHINA, 104(37), 3506¿3512. HTTPS://DOI.ORG/10.3760/CMA.J.CN112137-20240329-00722 OBJECTIVE: TO COMPARE THE ACCURACY AND SAFETY OF ROBOT-ASSISTED AND NAVIGATION-ASSISTED SCREW PLACEMENT IN ATLANTOAXIAL DISLOCATION SURGERY. METHODS: A RETROSPECTIVE ANALYSIS WAS CONDUCTED ON THE CLINICAL DATA OF 49 PATIENTS WITH ATLANTOAXIAL DISLOCATION TREATED CONSECUTIVELY AT THE HONGHUI HOSPITAL OF XI'AN JIAOTONG UNIVERSITY FROM APRIL 2022 TO DECEMBER 2023. AMONG THEM, 27 WERE MALE AND 22 WERE FEMALE, AGED (44.2±11.7) YEARS. BASED ON THE DATE OF SURGERY, 29 PATIENTS (FROM APRIL 2022 TO APRIL 2023) RECEIVED THE S8 NAVIGATION-ASSISTED SCREW PLACEMENT (NAVIGATION GROUP), 20 PATIENTS (FROM MAY TO DECEMBER 2023) RECEIVED MAZOR ROBOT-ASSISTED SCREW PLACEMENT (ROBOT GROUP). THE ACCURACY OF SCREW PLACEMENT, SCREW PLACEMENT TIME, OPERATION TIME, INTRAOPERATIVE BLOOD LOSS, AND INTRAOPERATIVE COMPLICATIONS WERE RECORDED AND COMPARED B

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 THE PATIENT HAD PERMANENT INJURIES, PAIN, SUFFERING, AND LOSS OF ENJOYMENT OF LIFE, AS A RESULT OF THE PROCEDURE.

VELYS — 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 TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHILE USING THE ROBOTIC-ASSISTED SOLUTION SATELLITE STATION DEVICE A CUT WAS MADE "THAT WAS NOT APPROPRIATE." IT WAS REPORTED THAT WHILE PLACING THE IMPLANT THE ANTERIOR CUT WAS OFF. IT WAS REPORTED THAT A REVISION HAD TO BE MADE TO THE IMPLANT AND THE CONDYLE WAS FRACTURED DURING THE CASE. IT WAS REPORTED THAT THE POINTER HAD NOT BEEN USED FOR VERIFICATION. IT WAS REPORTED THAT THE CUT ON THE FEMUR HAD NOTCHED THE ANTERIOR CORTEX. IT WAS REPORTED THAT THE DEVICE WAS BEING USED WITH A ROBOTIC ASSISTED BASE STATION DEVICE. THERE WERE NO DELAYS IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THIS IS REPORT 1 OF 2 FOR (B)(4).

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.

VELYS — 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 TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHILE USING THE ROBOTIC-ASSISTED SOLUTION SATELLITE STATION DEVICE A CUT WAS MADE "THAT WAS NOT APPROPRIATE". IT WAS REPORTED THAT WHILE PLACING THE IMPLANT THE ANTERIOR CUT WAS OFF. IT WAS REPORTED THAT A REVISION HAD TO BE MADE TO THE IMPLANT AND THE CONDYLE WAS FRACTURED DURING THE CASE. IT WAS REPORTED THAT THE POINTER HAD NOT BEEN USED FOR VERIFICATION. IT WAS REPORTED THAT THE CUT ON THE FEMUR HAD NOTCHED THE ANTERIOR CORTEX. IT WAS REPORTED THAT THE DEVICE WAS BEING USED WITH A ROBOTIC ASSISTED BASE STATION DEVICE. THERE WERE NO DELAYS IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THIS IS REPORT 2 OF 2 FOR (B)(4).

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 SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS ¿LOOSE AND BROKEN AWAY FROM THE INSTRUMENT.¿ NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER DID NOT HAVE A CUT OR TEAR. NO ARCING WAS OBSERVED. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE. THE ORANGE SURFACE WAS NOT VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. INSTALLATION TOOL WAS USED. THE LUBRICANT WAS NOT APPLIED TO THE MCS INSTRUMENT PRIOR TO THE TIP COVER INSTALLATION. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THE TIP COVER ACCESSORY FELL INSIDE THE PATIENT¿S ANATOMY, AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE FRAGMENT. THE CUSTOMER USED A BACKUP MCS TIP COVER ACCESSORY TO RESOLVE THE ISSUE.

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 LITERATURE ARTICLE DESCRIBED A COMPARATIVE ANALYSIS BETWEEN MARCH 2014 AND OCTOBER 2023 OF PATIENTS WHO UNDERWENT DA VINCI-ASSISTED RADICAL PROSTATECTOMIES. THE AIM WAS TO COMPARE PERIOPERATIVE AND EARLY SURGICAL OUTCOMES OF EXTRAPERITONEAL SINGLE PORT (SP)- VS TRANSPERITONEAL MULTIPORT (MP) - ROBOT ASSISTED RADICAL PROSTATECTOMY (RARP) IN DIFFERENT FRAILTY SETTINGS. A TOTAL OF 549 PATIENTS WERE ASSESSED IN AN UNMATCHED ANALYSIS. AFTER THE PROPENSITY SCORE, 252 PATIENTS WERE IDENTIFIED. THE PATIENTS (WHO HAD A MEDIAN AGE OF 64 YEARS) WERE SPLIT INTO TWO GROUPS, 126 IN THE SP GROUP AND 126 IN THE MP GROUP. A 5-ITEM MODIFIED FRAILTY INDEX (5-MFI) WAS USED TO IDENTIFY PATIENTS WHO WILL BENEFIT FROM SURGERY AND FORECAST THE RELATED MORBIDITY. THE ANALYSIS REPORTED, OF THE 252 PATIENTS, THERE WAS A TOTAL OF 5 INTRAOPERATIVE COMPLICATIONS, 1 OPEN CONVERSION, AND 27 30-DAYS POSTOPERATIVE COMPLICATIONS WITH A CLAVIEN-DINDO GRADE III OR HIGHER. THE SPECIFICS OF THE COMPLICATIONS AND CONVERSION (AND ANY REQUIRED MEDICAL INTERVENTIONS) WERE NOT REPORTED IN THE ARTICLE. THE MP RARP GROUP (COMPARED TO THE SP RARP GROUP) HAD HIGHER INCIDENCES OF INTRAOPERATIVE COMPLICATIONS (4 VS. 1) OPEN CONV

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 AFTER THE MONARCH BRONCHOSCOPY CASE WAS COMPLETED SUCCESSFULLY PATIENT EXPERIENCED A PNEUMOTHORAX SAME DAY. CHEST TUBE IS BEING EMPLANED TO ADDRESS PNEUMOTHORAX. PHYSICIAN DOES NOT ATTRIBUTE THIS EVENT TO MONARCH AND CONSIDERS IT A NORMAL RISK OF A PLURAL TARGET.

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 VENTRAL HERNIA IPOM SURGICAL PROCEDURE, THE JAW OF THE HARMONIC ACE INSTRUMENT BROKE OFF WHILE INSIDE OF THE PATIENT. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE USER COMPLETED THE PROCEDURE, AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

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.

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.

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.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MPS REPORTED THAT THE ANTERIOR CHAMFER CUT IS CONSTANTLY DEEP. THE MPS MENTIONED THAT THEY'VE BEEN GETTING SERVICE FOR THIS SAME ISSUE EVERY MONTH OR TWO FOR THE PAST YEAR. ON THE LAST CASE THE CUT WAS SO DEEP THAT THEY HAD TO GRAFT THE BONE TO GET THE IMPLANT TO FIT PROPERLY. MPS IS CONFIDENT THAT THE SURGEON IS NOT PUSHING AGAINST THE BUMP COMPLAINT FORM: - CUTS WITH THE ROBOT WERE INACCURATE. THIS HAS BEEN A CONSISTENT PROBLEM WITH MY ROBOT, WITH MANY SERVICE CALLS TO ADDRESS THIS ISSUE. ANTERIOR CHAMFER CUT WAS 2 TO 3 MM DEEP, HAD TO BONE GRAFT THE IMPLANT TO MAKE IT FIT- I DON'T THINK ITS A SURGEON TECHNIQUE ISSUE . HE REFUSED TO USE THE PLANAR PROBE. HE IS GETTING SO FRUSTRATED THAT CUTS ARE CONSISTENTLY OFF WITH THIS ROBOT HE IS THREATENING TO STOP USING THE ROBOT. CUTS WILL BE ACCURATE FOR A FEW WEEKS AFTER A SERVICE AND THEN CONSISTENTLY GET BAD AGAIN. I WOULD SAY 2 OR 3 TKA SURGERIES OUT OF FIVE WE WILL HAVE TO BONE GRAFT AT LEAST ONE PLACE ON THE FEMUR TO GET GOOD FIT WITH THE PRESS-FIT IMPLANTS. ROBOT NEEDS TO BE SERVICED. CASE TYPE / APPLICATION: TKA 2.0.

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.

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 WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS ¿LOOSE AND BROKEN AWAY FROM THE INSTRUMENT.¿ THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER WAS CUT/TORN ON THE CLEAR AREA. NO ARCING WAS OBSERVED. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE. THE ORANGE SURFACE WAS NOT VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. THE INSTALLATION TOOL WAS USED. THE LUBRICANT WAS NOT APPLIED TO THE MCS INSTRUMENT BEFORE THE TIP COVER INSTALLATION. THE TIP COVER ACCESSORY FELL INSIDE THE PATIENT¿S ANATOMY, AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE FRAGMENT. THE CUSTOMER USED A BACKUP MCS TIP COVER ACCESSORY TO RESOLVE THE ISSUE.

The consent order addresses Cruise's failure to disclose the details of an October 2023 incident in which a Cruise vehicle, operating autonomously, dragged a pedestrian several feet before coming to a stop. According to NHTSA's press release, Cruise will pay a total monetary penalty of $1.5 million, and is required to submit to NHTSA a corrective action plan on how it will improve its compliance with the Standing General Order.

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.

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 DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, A SMALL BLACK CHUNK OF RUBBER FROM THE UNIVERSAL SEAL DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED.

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.

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 THYMECTOMY PROCEDURE, THE SURGEON WAS NOT ABLE TO REACH THE THORACIC SPACE APPROPRIATELY FROM THE SUB-XIPHOID PORT WHEN USING THE DA VINCI SINGLE-PORT (SP) SYSTEM. THE SURGEON THEN ELECTED TO CONVERT TO THE CASE USING A DA VINCI XI MULTI-PORT (MP) SYSTEM. ADDITIONAL PORTS WERE PLACED WHEN CONVERTING FROM SINGLE-PORT TO MULTI-PORT SURGERY. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE SURGEON SAID THE CONVERSION FROM SP TO MP DID NOT AFFECT THE PATIENT OUTCOME; THE PATIENT DID WELL. THE SURGEON ELECTED TO CONVERT TO MULTI-PORT DUE TO ANATOMIC RESTRAINTS OF NARROW SPACE, CARDIOMEGALY, AND A PRIOR HEART SURGERY.

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 WITHOUT ROBOT.

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 SHORTLY AFTER THE PATIENT DISPLAYED SUSPECTED PRESENCE OF STROKE AND/OR HEMATOMA.

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 EXCELSUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIRTY-NINE-YEAR-OLD FEMALE PRESENTED TO ((B)(6) HOSPITAL) FOR ELECTIVE ROBOT ASSISTED LAPAROSCOPY FOR MYOMECTOMY FOR FIBROID UTERUS. DURING THE PROCEDURE, THE PERMANENT CAUTERY SPATUAL 8MM BROKE OUT OF THE ELBOW OF THE ROBOT DURING USE INSIDE THE PATIENT'S ABDOMEN. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN INSTRUMENT AND THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE AND THE PIECE WAS REMOVED.

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 MERGE ISSUE.

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.

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 HYSTERECTOMY WITH BILATERAL SALPINGECTOMY PROCEDURE, THE SURGEON NOTICED A SMALL BLACK FOREIGN BODY INSIDE THE PATIENT WHILE TAKING DOWN ADHESIONS. THE FOLLOWING INFORMATION IS UNKNOWN: THE SOURCE OF THE FOREIGN BODY, THE CAUSE OF THE FOREIGN BODY, IF THE CUSTOMER WAS ABLE TO RETRIEVE THE FOREIGN BODY, AND THE PROCEDURE OUTCOME. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED 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 GASTRIC BYPASS ROUX-EN-Y SURGICAL PROCEDURE, THE SYNCHROSEAL WAS CUTTING, BUT THE CAUTERY WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: TISSUE WAS BEING TORN BUT NOT SEALED. NO REPAIR WAS NEEDED TO THE TORN TISSUE AND MINIMAL EXPECTED SURGICAL BLEEDING OCCURRED. THERE WAS NO BLOOD TRANSFUSION NEEDED. THEY OPENED A BACKUP SYNCHROSEAL TO RESOLVE THE ISSUE. THE ORIGINAL SYNCHROSEAL DID NOT WORK AT ALL. IT DID THROW AN ERROR CODE, BUT THE REPORTING PERSON WAS NOT PRESENT. THERE WAS NO CONTINUOUS TONE, IT JUST KEPT BEEPING. NO TONES WERE NOTED THAT SEAL WAS SUCCESSFUL. THERE WERE NO VIDEO RECORDINGS.

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.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) RECEIVED A VOLUNTARY MEDWATCH REPORT (MDR) WITH THE FOLLOWING EVENT DESCRIPTION: "DURING THE SURGERY, A PIECE OF THE ROBOTIC HARMONIC SHEARS BROKE OFF. IT OCCURRED WHILE THE SURGEON WAS CAUTERIZING THE TISSUE WITH THE SHEARS. THE BROKEN PIECE WAS RECOVERED."

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WANDVIK, CAITLYN, ET AL. ¿LIMITATIONS OF CURRENT ROBOT-ASSISTED PEDICLE SCREW INSERTION SYSTEMS.¿ NEUROSURGICAL FOCUS, VOL. 57, NO. 6, 1 DEC. 2024, HTTPS://DOI.ORG/10.3171/2024.9.FOCUS24545. OBJECTIVE: AS ROBOT SYSTEMS FOR SPINE SURGERY HAVE BEEN DEVELOPED, THEY HAVE DEMONSTRATED A HIGH DEGREE OF ACCURACY IN SCREW PLACEMENT WITHOUT SACRIFICING SAFETY OR SURGICAL EFFICIENCY. THESE ROBOTIC SYSTEMS OFFER PREOPERATIVE PLANNING AND REAL-TIME FEEDBACK TO ENHANCE SURGICAL PRECISION AND MITIGATE HUMAN ERROR. NEVERTHELESS, LIMITATIONS TO THEIR OPTIMAL PERFORMANCE REMAIN. THE AUTHORS ANALYZED THE INITIAL 100 CASES OF PEDICLE SCREW PLACEMENTS PERFORMED USING THE MAZOR X ROBOT AT THEIR INSTITUTION, PRESENTING CASE EXAMPLES TO ILLUSTRATE THE LIMITATIONS THAT WERE EXPERIENCED, AND REVIEWED CURRENT LITERATURE ON THE LIMITATIONS OF ROBOT-ASSISTED SPINE SURGERY, EMPHASIZING THEIR IMPACT ON ACCURACY AND SAFETY. METHODS: THIS WAS A RETROSPECTIVE REVIEW OF THE FIRST 100 CASES OF ROBOT-ASSISTED PEDICLE SCREW PLACEMENT AT THE AUTHORS¿ INSTITUTION BETWEEN DECEMBER 2019 AND JUNE 2024. ALL INTRAOPERATIVE CT SCANS WERE REVIEWED FOR SCREW ACCURACY. MALPOSITIONED SCREWS, NEAR MISSES (SCREW DEVIATION WITHOUT I

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.

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.

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 INGUINAL HERNIA SURGICAL PROCEDURE, THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THE RIGHT EYE OF THE CONSOLE WAS BLACK. THE CUSTOMER STATED STAFF WAS IN THE PROCESS OF RESEATING THE ENDOSCOPE AND PERFORMING A POWER CYCLE OF THE SYSTEM, BUT THE ISSUE REMAINED. THE ISI TSE REVIEWED THE LOGS AND FOUND ENDOSCOPE COMMUNICATION ISSUES. THE TSE RECOMMENDED A HARD POWER CYCLE OF THE CONSOLE WHEN POSSIBLE. THE CUSTOMER WAS PLANNING TO LET THE STAFF KNOW AND CALL BACK IF THE HARD POWER CYCLE WOULD NOT RESOLVE THE ISSUE AND THE CALL ENDED. ISI CLINICAL SALES REPRESENTATIVE (CSR) CALLED BACK IN TO REPORT THEY TRIED A HARD REBOOT, BUT THE RIGHT EYE OF THE CONSOLE WAS STILL BLACK. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS POWERED ON; ARMS WERE CHECKED FOR FUNCTIONALITY DURING THE DRAPING PROCESS. INTEGRATED ELECTROSURGICAL UNIT (IESU) POWERED ON AND FUNCTIONED WITH VISION TOWER. THE SURGEON WAS LOGGED INTO THE SURGEON CONSOLE WITHOUT ISSUE BUT VISION THROUG

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.

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.

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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: GRIEPP, D. W., CASKEY, J., BUNJAJ, A., TURNBULL, J., ALSALAHI, A., ALEXANDER, H., DRAGONETTE, J., SARCAR, B., DESAI, S., TONG, D., SOO, T. M., BONO, P., KELKAR, P., HOUSEMAN, C., CLAUS, C. F., RICHARDS, B. F., CARR, D. A. (2024). IRRADIATION SAFETY, ANESTHESIA TIME, SURGICAL COMPLICATIONS, AND PATIENT-REPORTED OUTCOMES IN THE ROBOTIC MAZOR X VERSUS FLUOROSCOPY GUIDED MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION SURGERY: A COMPARATIVE COHORT STUDY. NEUROSURGICAL FOCUS, 57(6). HTTPS://DOI.ORG/10.3171/2024.9.FOCUS24489 OBJECTIVE: ROBOT-ASSISTED (RA) TECHNOLOGY IS BECOMING MORE WIDELY INTEGRATED AND ACCEPTED IN SPINE SURGERY. THE AUTHORS SOUGHT TO EVALUATE OPERATIVE AND PATIENT-REPORTED OUTCOMES (PROS) IN RA VERSUS FLUOROSCOPY-ASSISTED (FA) PEDICLE SCREW PLACEMENT DURING MINIMALLY INVASIVE SURGERY (MIS) TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). METHODS: THE AUTHORS RETROSPECTIVELY STUDIED ELECTIVE PATIENTS WHO UNDERWENT SINGLE- OR MULTILEVEL MIS TLIF FOR DEGENERATIVE INDICATION USING FA VERSUS RA PEDICLE SCREW PLACEMENT. PATIENTS WERE SELECTED FROM SEPTEMBER 2021 TO MAY 2023 AT A SINGLE INSTITUTION WITH MULTIPLE SURGEONS WHOSE PRACTICE CONSISTS OF PRIMARILY MIS. OUTCO

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.

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 LITERATURE ARTICLE THAT DESCRIBED A RETROSPECTIVE COHORT STUDY, INCLUDING CONSECUTIVE PATIENTS THAT UNDERWENT THORACIC SURGERY IN A SINGLE CENTER FROM FEBRUARY 2014 TO JANUARY 2023. ROBOTIC THORACIC SURGERY WAS USED IN ANATOMICAL LUNG RESECTION IN 85% OF THE CASES. OVER THE STUDY PERIOD, 1,067 PATIENTS UNDERWENT ROBOTIC SURGERY: 509 HAD LOBECTOMIES AND 391 HAD SEGMENTECTOMIES. THERE WERE 30 CONVERSIONS TO THORACOTOMY (2.8%) OF WHICH 7 WERE EMERGENCIES. SIX CONVERSIONS WERE DUE TO BLEEDING AND 1 CASE WAS CONVERTED DUE TO AN UNSPECIFIED ANESTHESIA ISSUE. THE MENTIONED POSTOPERATIVE COMPLICATIONS WERE REFRACTORY LUNG INFECTION, STROKE AND ONE FISTULA. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED. THE AUTHOR ALSO DID NOT ALLEGE THAT ANY INTUITIVE SURGICAL INC (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO THE COMPLICATIONS. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS BEEN RECEIVED.

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 SURGICAL PROCEDURE, THE USER NOTICED THAT THE HARMONIC ACE INSTRUMENT HAD A BROKEN BLADE. THE BLADE FELL INTO THE PATIENT'S ANATOMY AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED USING FORCEPS INSTRUMENTS AND CONFIRMED VIA VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURES OR POST-OPERATIVE TESTS WERE PERFORMED. THERE WAS NO REPORT OF POST-SURGICAL COMPLICATIONS, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL. THE SURGEON WAS DISSECTING TISSUE WHEN THE FRAGMENTS FELL INTO THE PATIENT. THE INSTRUMENT WAS USED LESS THAN AN HOUR BEFORE THE EVENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE STAFF DID NOT FEEL ANY RESISTANCE TO THE REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED, AND THE SU

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 THE CUSTOMER HAD SOME CONCERNS WITH THE DA VINCI SYSTEM "NOT BEING INTUITIVE WITH THE MOTIONS BUT LIKE SOMETHING ELSE". THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL DETAILS AT THE TIME. THE FIELD SERVICE ENGINEER (FSE) NOTED THAT THE CASE WAS CONVERTED FROM A SINGLE PORT TO MULTI-PORT AND EXTENDED. THERE WAS NO REPORTED INJURY.

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 POST OP CT SCAN SHOWS A MEDIAL BREACH OF THE L1R SCREW.

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 BARIATRIC SURGICAL PROCEDURE, A FRAGMENT FROM AN UNKNOWN INSTRUMENT FELL INSIDE THE PATIENT'S ANATOMY AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED.

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 CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE DOCTOR WAS 1-2 MM OFF ON THE CERVICAL. IT WAS THE RIGHT C4 THAT THE DOCTOR FELT INACCURATE. THE PATIENT LOST BLOOD (500CC'S). BLEEDING WAS ABLE TO BE CONTROLLED. THE PROCEDURE WAS DELAYED 10 MINUTES.

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, A T10 TO T4 EXTENSION TO A PREVIOUS CONSTRUCT. IT WAS REPORTED THAT THE SURGEON STARTED INSERTING ALL SCREWS ON THE RIGHT SIDE FIRST, STARTING FROM T10 AND GOING DOWN TO T4. WHEN THE SURGEON TAPPED T4, THE NON-MEDTRONIC NEUROMONITORING SYSTEM INDICATED THAT ALL MOTOR FUNCTIONS WERE LOST IN THE PATIENT'S LOWER EXTREMITIES. THE SURGEON USED A BALL-TIP SEALER TO FEEL THAT THERE WAS NO WALL ON THE MEDIAL SIDE OF THE T4 PEDICLE. THEY WERE UNSURE WHY TAPPING WAS INACCURATE BUT SUSPECTED EITHER SKIVING OR PATIENT MOVEMENT. THEY DID NOT OBSERVE ANY SOFT TISSUE PRESSURE ON THE CANNULA NOR DEFLECTION OF THE CANNULA FROM THE GELPEE. THE SURGEON ALSO DID NOT OBSERVE ANY CEREBROSPINAL FLUID (CSF) LEAKAGE. THE SURGEON MOVED THE ROBOT OUT OF THE WAY AND USED FREEHAND NAVIGATION TO INSERT THE SCREW AT T4. THE SURGEON FELT THAT THE T4 SCREW ON THE RIGHT SIDE WAS SCREWED APPROPRIATELY. THE SURGEON THEN ABORTED NAVIGATION ENTIRELY AND PROCEEDED TO COMPLETE THE CASE BY INSERTING THE T10 THROUGH T4 SCREWS ON THE LEFT SIDE BY FREEHAND. THE SURGEON WAS FRUSTRATED BECAUSE OF THE PATIENT HARM, BUT WILL CONTINUE