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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE SURGEON VISUALLY FOUND BLACK PIECES INSIDE THE PATIENT THAT POSSIBLY CAME FROM THE CANNULA SEAL. THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. 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.

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 CHOLECYSTECTOMY PROCEDURE, THE SURGEON VISUALLY FOUND BLACK PIECES INSIDE THE PATIENT THAT POSSIBLY CAME FROM A UNIVERSAL SEAL (I.E. CANNULA SEAL). THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. ACCORDING TO THE INITIAL REPORTER, THE CUSTOMER WILL BE RETURNING 4 UNIVERSAL SEALS THAT WERE USED DURING THE CASE.

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 CHOLECYSTECTOMY PROCEDURE, THE SURGEON VISUALLY FOUND BLACK PIECES INSIDE THE PATIENT THAT POSSIBLY CAME FROM A UNIVERSAL SEAL (I.E. CANNULA SEAL). THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. ACCORDING TO THE INITIAL REPORTER, THE CUSTOMER WILL BE RETURNING 4 UNIVERSAL SEALS THAT WERE USED DURING THE CASE.

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 SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED AN "ACTIVATION HAS BEEN INTERRUPTED" MESSAGE ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR WAS DISPLAYED. THE PATIENT WAS ON THE TABLE UNDER ANESTHESIA WITH PORTS PLACED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) ASKED THE CUSTOMER TO PULL THE IESU GENERATOR POWER AND IT POWERED ON WITH A FAULT. THE CUSTOMER DID NOT HAVE ANOTHER DA VINCI SP TOWER TO USE. THE ISI CLINICAL SALES REPRESENTATIVE (CSR) STATED THAT THE SURGEON WAS PLANNING TO RE-SCHEDULE SURGERY AND THE PROCEDURE WAS ABORTED.

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 WITH EXTRAPERITONEAL LYMPHADENECTOMY PROCEDURE, TISSUE WAS INSUFFICIENTLY SEALED, AND BLEEDING OCCURRED. THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE, AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY OBSERVED. THE ISSUE OCCURRED DURING THE SEALING SEQUENCE, AND INSTEAD OF HEARING A CONTINUOUS TONE WHILE THE PEDAL WAS PRESSED, A SHORT TONE WAS HEARD. THE DESIRED TISSUE EFFECT COULD BE SEEN, BUT AT THE COMPLETION OF THE SEALING CYCLE; ONLY ONE TONE WAS HEARD INSTEAD OF THREE ASCENDING FAST AUDIBLE TONES. AN ERROR MESSAGE OF ¿TAKE THE RIGHT AMOUNT OF TISSUE¿ WAS OBSERVED. THE SURGEON BELIEVES THAT THE SYNCHROSEAL INSTRUMENT STOPPED SEALING TOO EARLY, CAUSING BLEEDING WHEN THE TISSUE WAS CUT. THE AMOUNT OF BLEEDING WAS NOT SPECIFIED BUT WAS REPORTED AS ¿NOT CRITICAL¿ AND WAS RESOLVED USING DIATHERMY; THE PATIENT DID NOT REQUIRE A TRANSFUSION OF BLOOD PRODUCTS. A TECHNICAL SUPPORT ENGINEER (TSE) WAS CALLED TO HELP TROUBLESHOOT THE ISSUE; THE ERROR LOGS WERE REVIEWED WITH NO ERRORS WERE IDENTIFIED. TSE ADVISED USE OF A NEW SYNCHROSEAL INSTRUMENT, AND THE INSTRUMENT WAS REPLACED BY A BACKUP; HOWEVER, THE

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 "SHORT-TERM OUTCOMES OF DA VINCI SP VERSUS XI FOR RECTAL CANCER SURGERY: A PROPENSITY SCORE MATCHING ANALYSIS OF TWO TERTIARY CENTER COHORTS" DESCRIBED A RETROSPECTIVE ANALYSIS. PATIENTS WHO UNDERWENT ROBOTIC SURGERY FOR RECTAL ADENOCARCINOMA FROM JANUARY 2016 TO SEPTEMBER 2023 AT TWO TERTIARY REFERRAL CENTERS WERE INCLUDED IN THE ANALYSIS. A TOTAL OF 378 PATIENTS WERE ANALYZED: 65 PATIENTS UNDERWENT DA VINCI-ASSISTED SP RECTAL CANCER SURGERY AND 378 PATIENTS UNDERWENT DA VINCI-ASSISTED XI RECTAL CANCER SURGERY. THE STUDY WAS CONDUCTED TO COMPARE KEY PARAMETERS BETWEEN PATIENT COHORTS BEFORE AND AFTER PROPENSITY SCORE MATCHING. THE ARTICLE MENTIONED THAT THERE WERE NO DIFFERENCES IN COMPLICATION RATES AND MAJOR COMPLICATION RATES. THE ARTICLE NOTED THAT IN THE SP GROUP, THE COMPLICATIONS INCLUDED 4 CASES OF ANASTOMOSIS LEAKS WHICH WERE TREATED WITH DIVERSION ILEOSTOMY, AND 2 CASES OF OTHER UNKNOWN COMPLICATIONS. THERE WERE NO INSTANCES OF INTRA-ABDOMINAL ABSCESS/FLUID COLLECTION, ILEUS, OR POSTOPERATIVE BLEEDING. ADDITIONALLY, THERE WAS 1 CASE OF READMISSION. THE AUTHORS CONCLUDED THAT THE DA VINCI SP SYSTEM CONTINUES TO OFFER MINIMAL INVASIVE BENEFITS IN RECTA

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 SURGICAL PROCEDURE, THE PATIENT CALLED TO REPORT CONTINUED PAIN. THE PATIENT WENT TO ANOTHER HOSPITAL NEARBY AND AN X-RAY WAS PERFORMED. THROUGH THE X-RAY, A FRAGMENT INSIDE OF THE PATIENT WAS FOUND. THE FRAGMENT WAS RETRIEVED THROUGH THE ADDITIONAL SURGERY AT ANOTHER HOSPITAL. THE PATIENT WAS CALLING TO INVESTIGATE WHAT THE FRAGMENT WAS AND WHETHER THE FRAGMENT WAS TOXIC. THE PATIENT WOULD LIKE TO KNOW IF THE FRAGMENT HAD FALLEN FROM AN INTUITIVE INSTRUMENT OR NOT. THE PATIENT SENT PHOTOS OF THE FRAGMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HOSPITAL IS AWARE OF THE ALLEGATION FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS AN INVESTIGATION ALLEGATION. AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE HOSPITAL, AND THEY STATED THAT THERE WERE NO ISSUES DURING THE PROCEDURE AT THE TIME. IT IS UNKNOWN WHERE THE PIECE CAME FROM; THE PATIENT SUSPECTS THAT THE FRAGMENT CAME FROM A DA VINCI INSTRUMENT.

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 THERE WAS A CONCERNING INCREASE IN SPINE SURGICAL SITE INFECTIONS (SSIS) ASSOCIATED WITH THE GUIDANCE SYSTEM ROBOT. THE INFECTION RATE HAD TRIPLED COMPARED TO FISCAL YEAR 2024, WITH SEVEN FUSION INFECTIONS REPORTED IN FY2025, FIVE OF WHICH INVOLVED PROCEDURES UTILIZING THE GUIDANCE SYSTEM ROBOT. IT WAS NOTED THAT THE INSTRUMENT WAS NOT PROPERLY CLEANED AFTER STERILIZATION, AS OBSERVED USING A BORESCOPE DOWN THE CANNULA INSERTER. IN RESPONSE TO THESE FINDINGS, THE USE OF THE GUIDANCE SYSTEM ROBOT FOR SPINE SURGERIES WAS TEMPORARILY SUSPENDED EFFECTIVE (B)(6) 2025, WHILE FURTHER INVESTIGATION AND MITIGATION EFFORTS WERE UNDERTAKEN. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURES BEING PERFORMED WERE SACROILIAC AND THORACOLUMBAR PROCEDURES. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT MEDTRONIC FOUND NO ISSUES WITH ANY OF THE BIOLOGICS THAT WERE USED AND THE FOCUS SHIFTED TO OTHER POSSIBILITIES.

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 CUTTER'S HEAD BROKE OFF, AND THE INSTRUMENT WAS INSTALLED AND USED IN JUST FIVE MINUTES. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. A BACKUP DIFFERENT DV INSTRUMENT WAS USED. 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 INSTRUMENT WAS INSPECTED PRIOR TO USE AND THE OUTER PACKING HAD BEEN CHECKED. THE SURGEON WAS DISSECTING WHEN THE ISSUE OCCURRED. THE SURGEON BELIEVED THAT THE QUALITY OF THE INSTRUMENT CAUSED THE FAILURE; THE INSTRUMENT WAS IN USE FOR 5 MINUTES. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE; THE INSTRUMENT FAULTED SUDDENLY. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE FRAGMENT(S) DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE. THE WRIST WAS STRAIGHTENED. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRU

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 UROLOGY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS ¿LOOSE AND BROKEN AWAY FROM THE INSTRUMENT.¿ THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY DID NOT HAVE A CUT OR TEAR. NO ARCING WAS OBSERVED. THE CUSTOMER HAD USED THE MCS TIP COVER ACCESSORY INSTALLATION TOOL. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED ON THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE CUSTOMER DID NOT APPLY ANY LUBRICANT TO THE MCS INSTRUMENT PRIOR TO THE MCS TIP COVER ACCESSORY INSTALLATION. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THE MCS 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 MCS TIP COVER ACCESSORY. 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 RETROSPECTIVE ANALYSIS OF 268 PATIENTS WHO UNDERWENT A SUBXIPHOID THYMECTOMY BETWEEN (B)(6) 2011 AND (B)(6) 2022. THE AIM OF THE STUDY WAS TO EVALUATE THE FEASIBILITY OF SUBXIPHOID UNIPORTAL THYMECTOMY (SUT) AND SUBXIPHOID ROBOTIC THYMECTOMY (SRT) PROCEDURES. SIXTY-ONE PATIENTS UNDERWENT SRT PROCEDURES USING DA VINCI SI OR XI ROBOTIC SURGICAL SYSTEMS. THE MEDIAN AGE OF THE ENTIRE PATIENT COHORT COMPRISING 268 PATIENTS WAS 57 (AGE RANGE 47¿67) YEARS. THE ARTICLE NOTED THAT THAT DURING THE ROBOTIC SURGERIES, POST-OPERATIVE COMPLICATIONS WERE OBSERVED IN 5 PATIENTS: HEMORRHAGE IN ONE CASE, RESPIRATORY FAILURE IN ONE CASE, CHYLOTHORAX IN ONE CASE, PHRENIC NERVE PARALYSIS IN ONE CASE, AND RECURRENT NERVE PALSY IN ONE CASE. THE PATIENT WHO DEVELOPED CHYLOTHORAX UNDERWENT THORACIC DUCT LIGATION USING THE LATERAL APPROACH. NONE OF THE PATIENTS UNDERWENT A CONVERSION TO STERNOTOMY. NO MORTALITIES OCCURRED IN EITHER GROUP. NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHOR DID NOT ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT.

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 SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED NO VISION IN THE RIGHT EYE OF THE HIGH-RESOLUTION STEREO VIEWER (HRSV). THE SYSTEM HAD INITIALLY POWERED ON WITH NO ISSUES, AND THE TOUCHSCREEN VISION WAS FINE FOR BOTH THE LEFT AND RIGHT EYE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) SUGGESTED A HARD POWER CYCLE THE SURGEON SIDE CONSOLE (SSC); THE RIGHT EYE VISION WAS RESTORED BUT THE LEFT EYE VISION WAS BRIGHTER THAN THE RIGHT EYE. AS A RESULT OF THE CUSTOMER REPORTED ISSUE, THE SURGEON DECIDED TO ABORT THE PROCEDURE. INCISION PORTS HAD ALREADY BEEN PLACED ON THE PATIENT.

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.

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 RETROSPECTIVE COHORT REVIEW OF 16 PATIENTS FROM A SINGLE SURGEON UNDERGOING SINGLE-PORT ROBOTIC REVISION OF URETEROENTERIC STRICTURE (UES) FOLLOWING RADICAL CYSTECTOMY WITH URINARY DIVERSION FROM SEPTEMBER 2020 THROUGH JULY 2024. THE OBJECTIVE OF THIS STUDY IS TO PRESENT A SERIES OF CASES UTILIZING SINGLE-PORT ROBOT-ASSISTED REPAIR FOR (UES) TO DEMONSTRATE THE PROCEDURE'S SAFETY AND FEASIBILITY. THE ARTICLE DESCRIBED A PATIENT WHO HAD AN ILEAL CONDUIT WITH A STRICTURE OF 1 CM IN LENGTH ON THE RIGHT. THE TYPE OF STRICTURE REPAIR THAT THE PATIENT HAD WAS HEINEKE-MIKULICZ (HM) TISSUE REARRANGEMENT. THE PATIENT EXPERIENCED UROSEPSIS AND SEROMA THAT EVOLVED INTO SUPERFICIAL WOUND SEPARATION, WHICH WAS TREATED WITH WOUND PACKING AND HEALED BY SECONDARY INTENTION. THE ARTICLE MENTIONED ANOTHER SEROMA, AND INCISIONAL HERNIA THAT DID NOT REQUIRE OPERATIVE INTERVENTION AND WERE TREATED CONSERVATIVELY. TWO OTHER CASES REQUIRED CONVERSION TO OPEN DUE TO ANATOMY (ADHESIONS). THE STUDY INVESTIGATOR RESPONDED TO FOLLOW-UP AND REPORTED THAT THERE WERE NO DA VINCI DEVICE MALFUNCTIONS, THAT THE ROBOT WAS NOT THE CAUSE OF THE OF THE COMPLICATIONS AND THAT PATIENT DEMO

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 SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTED THAT THEIR MONOPOLAR CURVED SCISSORS (MCS) TIP FELL OFF DURING THE PROCEDURE. THE STAFF WAS ABLE TO RETRIEVE TIP AND CONTINUE ON WITH PROCEDURE WITH REPLACEMENT INSTRUMENT. THE CSR TO SEND INSTRUMENT IN FOR FAILURE ANALYSIS. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER WAS CONTINUING WITH 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BLADE ON HARMONIC ACE CURVED SHEATH SUDDENLY BROKE OFF. THE 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 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: 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.

da Vinci Surgical System — Death 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 PROCEDURE, AN UNSPECIFIED VESSEL WAS DAMAGED LEADING TO BLEEDING. THE PROCEDURE WAS CONVERTED TO OPEN; THE PATIENT ULTIMATELY EXPIRED. AN INTUITIVE CLINICAL TERRITORY ASSOCIATE (CTA) WHO WAS PRESENT IN THE OR DURING THE PROCEDURE REPORTED THAT WHEN THE INJURY TO THE VESSEL OCCURRED, THE SURGEON CLAMPED THE BLEEDING VESSEL WITH A ROBOTIC INSTRUMENT. THE SURGEON STATED THAT DURING THE OPEN PROCEDURE THEY COULD NOT OBTAIN FULL CONTROL OF THE BLEEDING. CHEST COMPRESSIONS WERE PERFORMED, BUT THE PATIENT EXPIRED ON THE OR TABLE. THE SURGEON STATED THAT, "THE COMPLICATION WAS NOT RELATED TO THE DEVICES BUT TO [THE] COMPLEXITY OF THE SURGERY AND DEGREE OF CANCER." COINCIDENTALLY, PRIOR TO THE VESSEL INJURY EVENT, THE CTA CALLED INTUITIVE TECHNICAL SUPPORT ENGINEERING (TSE) TO REPORT THAT WHEN SWAPPING INSTRUMENTS, THE UNIVERSAL SURGICAL MANIPULATOR 3 (USM ARM3) WOULD JUMP MORE THAN NORMAL AND WOULD CANCEL GUIDED TOOL CHANGE (GTC). THE (TSE) REVIEWED THE SYSTEM LOGS AND FOUND NO RELATED ERRORS AT THE TIME OF THE CALL. THE CTA ALSO REPORTED A SYNCHROSEAL INSTRUMENT IN USE ON USM ARM3 COULD ONLY ROTATE TO THE RIGHT. THE TSE

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.