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 COVER ACCESSORY SLIPPED OFF 2 TIMES WHILE DISSECTING TISSUE. IT WAS CONFIRMED THAT THE SAME TIP COVER DETACHED BOTH TIMES. THE SURGEON BELIEVES THE ISSUE OCCURRED BECAUSE THE TIP COVER WAS DEFECTIVE. THE FRAGMENT WAS RETRIEVED BY THE ASSISTANT, AND VISUAL INSPECTION CONFIRMED THAT ALL FRAGMENTS WERE ACCOUNTED FOR. NO ADDITIONAL SURGICAL PROCEDURES, SUCH AS LAPAROSCOPY OR OPEN SURGERY, WERE REQUIRED TO RETRIEVE THE FRAGMENT, AND NO POST-OPERATIVE TESTS, LIKE X-RAYS OR ULTRASOUNDS, WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY USING A BACKUP TIP COVER TO CONTINUE. THERE WAS NO INJURY TO THE PATIENT, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO A RETAINED FOREIGN OBJECT.

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 PARTIAL NEPHRECTOMY PROCEDURE, THE GRAY PROTECTIVE SHEATH DISLODGED FROM THE SYNCHROSEAL INSTRUMENT AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS REMOVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. ON 04-FEB-2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT WITH UF/IMPORTER REPORT # (B)(4) STATING: GRAY INSULATED PROTECTIVE SHEATH DISLODGED FROM THE DA VINCI SYNCHROSEAL INTO THE SURGICAL FIELD. IT WAS LOCATED AND REMOVED." ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. WHEN THE EVENT OCCURRED, THE SURGEON WAS GRASPING UNSPECIFIED TISSUE AND THE SYNCHROSEAL INSTRUMENT HAD BEEN IN USE FOR ABOUT AN HOUR. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT PRIOR TO THE EVENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE USE. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE, PRIOR TO THE BREAKAGE WITH A STRAIGHTENED WRIST. UPON REMOVAL OF THE SYNCHROSEAL INSTRUMENT THROUGH THE CANNULA, THE INSTRUMENT'S

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 LIVER RESECTION PROCEDURE, THE BLADE OF A HARMONIC ACE INSTRUMENT FRACTURED WHEN THE SURGEON ACTIVATED THE INSTRUMENT. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT THE SURGEON INDICATED THAT HE DID NOT TOUCH ANYTHING HARD WITH THE INSTRUMENT BEFORE OR WHEN THE EVENT OCCURRED. THE CUSTOMER REMOVED THE FRACTURED PIECE OF THE BLADE FROM THE PATIENT DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE SURGICAL TASK BEING PERFORMED AT THE TIME OF THE DEVICE BREAKAGE WAS DISSECTION AND THE INSTRUMENT WAS IN USE FOR ABOUT HALF AN HOUR BEFORE THE EVENT OCCURRED. THE SURGEON DID NOT NOTICE ANY ISSUE WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE PRIOR TO BREAKAGE WITH THE INSTRUMENT'S WRIST STRAIGHTENED. THERE WAS NO RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. UPON FINAL REMOVAL OF THE INSTRUMENT, THE INSTRUMENT'S WRIST WAS AGAI

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: MY 35 YEARS OLD DAUGHTER UNDERWENT ELECTIVE SURGERY TO REMOVE HER UTERUS, USING THE DA VINCI ROBOTIC HD BY LAPAROSCOPY DUE TO FIBROIDS THAT DID NOT RESPONDED TO MEDICAL TREATMENT. SHE WAS PROGRAMED FOR HYSTERECTOMY AND POSSIBLE BILATERAL SALPINGECTOMY. THE SURGERY WAS PERFORMED ON (B)(6) 2024, AT (B)(6) HOSPITAL (B)(6). THE SURGERY WAS PROJECTED TO LAST TWO HOURS, STARTING AT 8 AM. AT ABOUT 2 PM, THE OBG DOCTOR CALLED MY DAUGHTER'S HUSBAND TO SAY, "THAT THERE WAS A SMALL COMPLICATION", AND THE PATIENT WOULD STAY AS A PRECAUTION AT THE INTENSIVE CARE UNIT (ICU). THE OBSTETRICS & GYNECOLOGIST (OBG) "SMALL COMPLICATION, WAS THAT WITH THE DEVICE TROCAR, SHE HAD CUT INTO THE PATIENT'S INFERIOR CAVA VEIN (THE LARGER IN THE BODY), SHE CUT THE PERITONEUM, SHE ALSO CUT PART OF THE INTESTINE AND SOME OF THE MESENTERIC ARTERIAL-VEINS VESSELS. THE LAPAROSCOPIC WAS CONVERTED TO OPEN HYSTERECTOMY. THE ANESTHESIOLOGIST IMMEDIATELY CALLED THE VASCULAR SURGEON FOR AN EMERGENCY REPAIR OF THE VESSELS INVOLVED. A GENERAL SURGEON WAS ALSO CALLED URGENTLY DUE TO DECREASING BLOOD PRESSURE AND SEVERE TACHYCARDIA. THE HYSTERECTOMY AND BILATERAL SALPINGECTOMY WAS COMPLICATED BY INFERIOR VENA CAVA INJURY STA

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, A BRANCH WAS BROKEN OFF OF THE HARMONIC ACE INSTRUMENT AND FELL INTO THE PATIENT DURING COAGULATION. THE PART WAS RECOVERED FROM THE PATIENT 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: 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 INNER LINING OF THE JAWS OF A HARMONIC ACE INSTRUMENT CAME OFF. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED. THE EVENT OCCURRED WHILE THE SURGEON WAS PERFORMING DISSECTION. IT IS UNKNOWN WHAT THE CAUSE OF THE INSTRUMENT BREAKAGE WAS. THE INSTRUMENT WAS IN USE FOR MORE THAN 30 MINUTES WHEN THE ISSUE OCCURRED AND THE SURGEON HAD NOT NOTICED ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT DURING AN INSTRUMENT TIP COLLISION. A VISUAL INSPECTION BY THE SURGEON CONFIRMED THAT ALL FRAGMENTS WERE REMOVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENTS. THERE WERE NO POSTOPERATIVE TESTS LIKE X-RAYS OR ULTRASOUNDS PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENC

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: A REVIEW OF AN ARTICLE WAS CONDUCTED WHICH EVALUATED PATIENTS WHO UNDERWENT ROBOTIC MULTI-VISCERAL RESECTION (RMVR) FOR A PRIMARY COLORECTAL CARCINOMA. THE RETROSPECTIVE STUDY ANALYZED 24 PATIENTS WHO UNDERWENT RMVR BETWEEN 2012 TO 2022. A TOTAL OF SIX PATIENTS EXPERIENCED COMPLICATIONS, CLAVIEN-DINDO GRADE III OR HIGHER, WHICH INCLUDED PELVIC FLUID COLLECTIONS NEEDING RADIOLOGICAL DRAINAGE AND INFECTIONS OF THE PERINEAL WOUND/FLAP NEEDING DRAINAGE UNDER LOCAL ANESTHESIA. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT ATTRIBUTE ANY EVENTS TO A DA VINCI DEVICE OR PRODUCT. THE STUDY CONCLUDED THAT FOR ADVANCED COLORECTAL CANCER, RMVR IS A SAFE AND ATTAINABLE PROCESS. ADDITIONAL INFORMATION WAS PROVIDED THROUGH FOLLOW-UP FROM THE CORRESPONDING AUTHOR: THE OPERATIONS DISCUSSED ARE COMPLEX AND THESE ARE EXPECTED FOR THIS GROUP OF PTS AND FOLLOWING NEOADJUVANT TREATMENT.

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 PARAESOPHAGEAL HIATAL HERNIA REPAIR PROCEDURE, THE COATING/METAL SHAVINGS ON SHAFT OF THE VESSEL SEALER EXTEND (VSE) INSTRUMENT SCRAPED OFF AND FELL INSIDE THE PATIENT'S ABDOMEN. THE INTUITIVE SURGICAL, INC. (ISI) CUSTOMER SALES REPRESENTATIVE (CSR) THAT WAS PRESENT DURING THE PROCEDURE STATED THAT THE SURGEON WAS ABLE TO REMOVE MOST OF THE METAL SHAVINGS. IT IS UNKNOWN IF ALL THE SHAVINGS WERE RETRIEVED. A POST OPERATIVE X-RAY WAS PERFORMED BUT THE RESULTS OF THE X-RAY ARE UNKNOWN. THE SURGEON REPORTED THAT THE PATIENT HAS NOT RETURNED WITH ANY POST-OPERATIVE 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 HYSTERECTOMY SURGICAL PROCEDURE, A PIECE OF PLASTIC BROKE OFF FROM THE UNIVERSAL SEAL AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME CASE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ACCESSORY WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. THE SURGEON DID NOT NOTICE ANY FUNCTIONALITY ISSUES PRIOR TO THE BREAKAGE, AND DID NOT KNOW WHAT CAUSED THE BREAKAGE. THERE WERE NO COLLISIONS. THERE WAS NO INSTRUMENT REMOVAL PRIOR TO THE BREAKAGE. THE SURGEON USED A GRASPER TO RETRIEVE THE FRAGMENT. ALL FRAGMENTS WERE RETRIEVED, WHICH WAS CONFIRMED BY VISUAL INSPECTION OF THE FRAGMENT AND PART. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING POST-SURGICAL COMPLICATIONS.

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. THIS EVENT OCCURRED IN SPAIN.

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, A FRAGMENT BROKE OFF A HARMONIC ACE CURVED SHEARS INSTRUMENT AND FELL INSIDE THE PATIENT. THE PIECE(S) WERE RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY.

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 AN INITIAL ROSA CEMENTLESS VANGUARD PS WAS PERFORMED WITH UNKNOWN INTRA-OPERATIVE PROBLEM. ON THE POST-OPERATIVE X-RAY, A COLLAPSE OF THE MEDIAL PLATEAU WAS SEEN AND A REVISION WAS PLANNED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; AT THIS TIME NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

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 ERROR OCCURRED. THE CUSTOMER REBOOTED THE SYSTEM, BUT ERROR 31057 OCCURRED REPEATEDLY, AND THE SYSTEM WAS INOPERABLE. THE SURGERY WAS CONVERTED TO OPEN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED DURING A BREAST CANCER SURGERY. THE PROCEDURE WAS CONVERTED TO OPEN, AND THERE WAS NO ADDITIONAL IMPACT 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 MYOMECTOMY-ENDOMETRIOSIS RESECTION SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE WHILE INSIDE THE PATIENT. IT WAS REPORTED A FRAGMENT FELL INSIDE THE PATIENT WHICH WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.

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 MAY 19, 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.

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 DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, A BLACK PIECE FELL OFF OF THE UNIVERSAL SEAL INSIDE THE PATIENT¿S ABDOMEN. 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 ACCESSORY WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE NOTED. THE SURGEON WAS REMOVING THE SUTURE WHEN THE FRAGMENT FELL INSIDE THE PATIENT. THE ISSUE WAS NOTED AT THE END OF THE CASE. THE SURGEON DID NOT NOTICE ANY ISSUE WITH THE FUNCTIONALITY OF THE ACCESSORY. THERE WAS NO COLLISION WITH OTHER INSTRUMENTS OR HARD MATERIALS DURING THE PROCEDURE. THE FRAGMENT DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP COLLISION. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE FRAGMENT WAS RETRIEVED, AND THE PIECE FIT THE TEAR OF THE CANNULA SEAL; NO OTHER TEARS OR PIECES WERE FOUND. NO ADDITIONAL SURGICAL PROCEDURES WERE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS LIKE X-RAYS OR ULTRASOUNDS WERE PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY; THERE

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.

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 MAY 19, 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.

At 10:35 a.m. on December 2, 2024, Employee #1 was performing maintenance on a sensor inside a robotic enclosure. As he entered the area, the robot was stopped by entrance sensors. While he was cleaning the sensor, a coworker reset the machine from the control panel, unaware that Employee #1 was still inside the enclosure. The robotic arm activated and struck Employee #1, reportedly lifting and placing him onto a roller platform. He sustained multiple internal and external injuries and was killed as a result of the 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 FROM A SOCIAL MEDIA POST THAT DURING DA VINCI-ASSISTED SURGERIES, THE UNIVERSAL CANNULA SEAL BROKE. IT IS UNCLEAR IF FRAGMENTS FELL INSIDE THE PATIENT AND IF SO, WERE THE FRAGMENTS RETRIEVED. THE SURGEON INDICATED THAT THE OCCURRED TWICE WITHIN THE LAST 2-3 WEEKS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PLUGGED THE EGPS INTO THE MAINS POWER SUPPLY AND NOT RECEIVING ANY POWER, TRIED MULTIPLE SOCKETS BUT NO POWER.

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 TITLED, "INCIDENCE OF INCISIONAL HERNIAS AFTER SINGLE-PORT VERSUS MULTI-PORT ROBOTIC-ASSISTED RADICAL PROSTATECTOMY," WAS PERFORMED. A TOTAL OF 493 PATIENTS UNDERWENT PRIMARY RARP WITH OR WITHOUT CONCOMITANT BILATERAL PELVIC LYMPH NODE DISSECTION VIA A TRANSPERITONEAL APPROACH. IN THE STUDY, 320 OF THESE PATIENTS UNDERWENT SINGLE-PORT ROBOTIC-ASSISTED RADICAL PROSTATECTOMY (SP-RARP) AND 173 UNDERWENT MULTI-PORT RARP (MP-RARP). THE ARTICLE NOTED THAT DURING THESE DA VINCI SURGERIES, MULTIPLE HERNIAS WERE REPORTED IN THE SP-RARP GROUP. TWENTY-SIX OF THESE PATIENTS DEVELOPED INCISIONAL HERNIAS (IH). ALL 26 PATIENTS, EXCEPT FOR TWO, WERE SYMPTOMATIC OR DIAGNOSED VIA PHYSICAL EXAMINATION DURING ROUTINE FOLLOW-UP. TWO OF THE PATIENTS UNDERWENT CT IMAGING IN THE EMERGENCY ROOM: ONE FOR ACUTE URINARY RETENTION WITH AN OBSTRUCTED FOLEY CATHETER AND ONE FOR A SYMPTOMATIC INCARCERATED HERNIA. OF THE 26 SP-RARP HERNIA PATIENTS, 10 REQUIRED SURGICAL REPAIR WITH MESH. THE STUDY CONCLUDED THAT PATIENTS WITH HIGHER BMIS AND PRIOR HISTORY OF ABDOMINAL SURGERIES ARE AT INCREASED RISK OF DEVELOPING POSTOPERATIVE INCISIONAL HERNIAS. SP-RARP PROCEDURES APPEAR TO HAVE A

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL OFF AN MCS INSTRUMENT. THE TIP COVER WAS NOT FOUND. DURING THE PROCEDURE, THE MCS TIP COVER ACCESSORY APPEARED TO HAVE BEEN PROPERLY INSTALLED AND THE INSTALLATION TOOL WAS USED WITHOUT ADDITIONAL LUBRICANT. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

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 BETWEEN AUGUST 2020 TO JANUARY 2023 OF 40 PATIENTS WHO UNDERWENT DA VINCI-ASSISTED SINGLE-PORT EXTRAPERITONEAL KIDNEY TRANSPLANTATION (SP EP-KT) PROCEDURES. THE MEDIAN AGE OF ALL PATIENTS WAS 54.45 (46.8-60.3) YEARS. THE MEDIAN BMI WAS 32.1 (29.8-37.4) KG/M2. THE 40 PATIENTS INCLUDED 24 MALES AND 16 FEMALES. THE STUDY WAS CONDUCTED TO EVALUATE "THE SAFETY AND FEASIBILITY OF THE SURGERY DEFINED AS SUCCESSFUL COMPLETION OF THE TRANSPLANT PROCEDURE WITHOUT ANY CONVERSION, ABORT OF PROCEDURE, OR POSTOPERATIVE GRAFT LOSS.". ONE CASE REQUIRED CONVERSION TO AN OPEN SURGERY DUE TO POOR ARTERIAL PULSATIONS AFTER COMPLETION OF VASCULAR ANASTOMOSIS WITH A DUSKY COLOR OF THE RENAL PARENCHYMA. THE PATIENT HAD AN UNEVENTFUL POSTOPERATIVE RECOVERY AND DID NOT HAVE SIGNIFICANT CLINICAL SEQUELAE OR GRAFT FAILURE. THE ARTICLE MENTIONED THERE WERE OTHER MAJOR UNSPECIFIED POSTOPERATIVE COMPLICATIONS (CLAVIEN-DINDO CLASSIFICATION OF GRADE III OR HIGHER) REPORTED IN FIVE PATIENTS IN THE FIRST 90 DAYS. IT WAS ALSO REPORTED THERE WERE 10 OTHER POSTOPERATIVE COMPLICATIONS AND NINE RE-ADMISSIONS WITHIN 90 DAYS OF SURGERY. THERE WAS NO REPORT OF MALFUNC

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 SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS HAVING DIFFICULTY BEING REMOVED FROM THE PATIENT. THE SCRUB TECHNICIAN ASKED THE SURGEON TO VISUALIZE THE INSTRUMENT WHILE SHE ATTEMPTED TO REMOVE IT. AFTER SEVERAL ATTEMPTS AND TROUBLESHOOTING SUCH AS RE-SEATING THE INSTRUMENT, PRESSING THE ROBOTIC BUTTONS, AND VARYING ANGLES OF PULL, THE SURGEON SCRUBBED IN AND REMOVED THE INSTRUMENT WITH FORCE. WHILE INSPECTING THE INSTRUMENT, THEY WERE ABLE TO OBSERVE THAT IT WAS BROKEN. THE BROKEN PIECE WAS REMOVED IN THE RETRIEVAL BAG WITH THE GALLBLADDER. THE CUSTOMER REMOVED THE INSTRUMENT FROM THE FIELD. THE TIP OF THE HARMONIC ACE JAW HAD BROKEN OFF AS WELL AS THE PORTION AROUND THE WRIST, WHICH WAS NOT KNOWN AT THE TIME AND UNACCOUNTED FOR WHEN REMOVING THE EQUIPMENT FROM THE FIELD AND THE PATIENT. IT IS UNKNOWN WHICH PORTION OF THE DAMAGE TO THE INSTRUMENT OCCURRED AT WHAT TIME. THE INSTRUMENT WAS STUCK AND NEEDED TO BE FORCEFULLY REMOVED. 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 SURGICAL PROCEDURE THE HARMONIC ACE INSTRUMENT BROKE TOWARDS THE BEGINNING OF THE CASE. A FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE ROBOTICALLY USING A BACKUP HARMONIC ACE INSTRUMENT.

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 LYMPHADENECTOMY PROCEDURE, THE FRONT END OF THE HARMONIC ACE INSTRUMENT WAS FRACTURED. THE FRACTURED PIECE FELL INSIDE OF THE PATIENT AND WAS REMOVED DURING THE SAME PROCEDURE. NO FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACKUP HARMONIC ACE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS 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: 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 HARMONIC ACE INSTRUMENT BROKE AT THE BEGINNING OF THE CASE. A FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE CASE WAS COMPLETED ROBOTICALLY USING A BACKUP HARMONIC ACE INSTRUMENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION PROCEDURE, THE HARMONIC ACE INSTRUMENT WOULD NOT PASS SELF-TESTING. THE SYSTEM LOGS SHOWED NO RELATED ERRORS. THE CUSTOMER EXPLAINED THAT WHILE PERFORMING A GENERATOR SELF-TEST, THERE WAS A PROMPT TO TIGHTEN THE INSTRUMENT. PRIOR TO CALLING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH NO CHANGE. THE TSE HAD THE CUSTOMER CLOSE THE CLAMP BY TURNING THE INPUT DISC ON THE HOUSING IN A COUNTERCLOCKWISE DIRECTION AND THEN ROTATE THE TORQUE WRENCH IN A CLOCKWISE DIRECTION UNTIL TWO LOUD CLICKS WERE HEARD. THE SELF-TEST THEN PASSED AND THE CUSTOMER WAS ABLE TO USE THE HARMONIC ACE INSTRUMENT. THE TSE RECOMMENDED RETURNING THE PREVIOUS HARMONIC ACE INSTRUMENTS FOR FAILURE ANALYSIS. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER PROCEEDED WITH THE CASE USING MULTIPLE HARMONIC ACE INSTRUMENTS; THE 4TH HARMONIC WAS FUNCTIONAL. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO THE LENGTH OF THE PROCEDURE AND NONFUNCTIONAL DEVICES. THE PA

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, HARMONIC ACE INSTRUMENT BROKE. A FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY.

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 HEMICOLECTOMY SURGICAL PROCEDURE, THE TIP COVER ACCESSORY FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. A POST-OPERATIVE X-RAY WAS PERFORMED; THE RESULT OF THE X-RAY IS UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TIP COVER FELL DURING REMOVAL OF THE INSTRUMENT. THE INSTRUMENT COLLIDED WITH ANOTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE, BUT THE FRAGMENT DID NOT FALL DURING AN INSTRUMENT TIP/ACCESSORY COLLISION. UPON FINAL REMOVAL, THE WRIST WAS NOT STRAIGHTENED, AND RESISTANCE WAS FELT; IT WAS POSSIBLE THAT THE WRIST WAS BENT. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA OR OTHER INSTRUMENT DAMAGE AFTER THE EVENT OCCURRED. THE TIP COVER WAS REMOVED USING A LAPAROSCOPIC INSTRUMENT. ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. A POST-OPERATIVE X-RAY WAS PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS. THE ASSOCIATED ACCESSORY WAS NOT AVAILABLE FOR RETURN.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION PROCEDURE, THE HARMONIC ACE INSTRUMENT WOULD NOT PASS SELF-TESTING. THE SYSTEM LOGS SHOWED NO RELATED ERRORS. THE CUSTOMER EXPLAINED THAT WHILE PERFORMING A GENERATOR SELF-TEST, THERE WAS A PROMPT TO TIGHTEN THE INSTRUMENT. PRIOR TO CALLING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH NO CHANGE. THE TSE HAD THE CUSTOMER CLOSE THE CLAMP BY TURNING THE INPUT DISC ON THE HOUSING IN A COUNTERCLOCKWISE DIRECTION AND THEN ROTATE THE TORQUE WRENCH IN A CLOCKWISE DIRECTION UNTIL TWO LOUD CLICKS WERE HEARD. THE SELF-TEST THEN PASSED AND THE CUSTOMER WAS ABLE TO USE THE HARMONIC ACE INSTRUMENT. THE TSE RECOMMENDED RETURNING THE PREVIOUS HARMONIC ACE INSTRUMENTS FOR FAILURE ANALYSIS. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER PROCEEDED WITH THE CASE USING MULTIPLE HARMONIC ACE INSTRUMENTS; THE 4TH HARMONIC WAS FUNCTIONAL. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO THE LENGTH OF THE PROCEDURE AND NONFUNCTIONAL DEVICES. THE PA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION PROCEDURE, THE HARMONIC ACE INSTRUMENT WOULD NOT PASS SELF-TESTING. THE SYSTEM LOGS SHOWED NO RELATED ERRORS. THE CUSTOMER EXPLAINED THAT WHILE PERFORMING A GENERATOR SELF-TEST, THERE WAS A PROMPT TO TIGHTEN THE INSTRUMENT. PRIOR TO CALLING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH NO CHANGE. THE TSE HAD THE CUSTOMER CLOSE THE CLAMP BY TURNING THE INPUT DISC ON THE HOUSING IN A COUNTERCLOCKWISE DIRECTION AND THEN ROTATE THE TORQUE WRENCH IN A CLOCKWISE DIRECTION UNTIL TWO LOUD CLICKS WERE HEARD. THE SELF-TEST THEN PASSED AND THE CUSTOMER WAS ABLE TO USE THE HARMONIC ACE INSTRUMENT. THE TSE RECOMMENDED RETURNING THE PREVIOUS HARMONIC ACE INSTRUMENTS FOR FAILURE ANALYSIS. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER PROCEEDED WITH THE CASE USING MULTIPLE HARMONIC ACE INSTRUMENTS; THE 4TH HARMONIC WAS FUNCTIONAL. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO THE LENGTH OF THE PROCEDURE AND NONFUNCTIONAL DEVICES. THE PA

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 BROKE TOWARDS THE BEGINNING OF THE CASE. A FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED USING BACKUP HARMONIC.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MAKO BILATERAL PKA SURGERY WAS PERFORMED. HOWEVER, THE CUTTER CHECK COULD NOT BE PASSED JUST BEFORE THE FIRST TIBIAL BONE CUTTING. THE SURGEON HAD NO CHOICE BUT TO DISCONTINUE THE PKA AND CLOSED THE INCISION SITE. REVISION SURGERY (MANUAL PKA) IS PLANNED INSTEAD OF MAKO PKA.

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 CURVED SHEARS BROKE AT THE BEGINNING OF THE PROCEDURE. A FRAGMENT FELL INTO THE PATIENT AND 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.

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 SURGICAL PROCEDURE, THE JAW OF THE HARMONIC ACE INSTRUMENT BROKE. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION AND CHOLECYSTECTOMY PROCEDURE, WHILE PUTTING A RAY-TEC SPONGE (A 3RD-PARTY MANUFACTURER PRODUCT) THROUGH A PORT, A PIECE OF A UNIVERSAL SEAL VALVE BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE AND THE UNIVERSAL SEAL WAS CHANGED.