da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS AN ERROR POINTING TO THE LEFT MASTER TOOL MANIPULATOR (MTM). THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTED A REPEAT RECOVERABLE FAULT WITH A PROMPT MESSAGE TO DISABLE THE LEFT MASTER TOOL MANIPULATOR (MTM). THE SYSTEM WAS STARTED AGAIN AND THE ISSUE CONTINUED. THE SITE ABANDONED THE CASE AFTER PORTS HAD BEEN PLACED. THE SYSTEM WAS NOT CONNECTED THROUGH ONSITE DURING THE CALL. THE PROCEDURE WAS ABORTED. ISI FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: UPON REVIEW, THE SYSTEM FUNCTIONALITY WAS NOT CHECKED UPON POWERING ON. FURTHERMORE, THE SYSTEM DID NOT POWER ON WITHOUT ERRORS; ERRORS WERE PRESENT FROM THE START. DESPITE THESE ISSUES, TECHNICAL SUPPORT WAS NOT CONTACTED FOR TROUBLESHOOTING AT THE TIME OF THE ISSUE FOR FULL TROUBLESHOOTING. FACED WITH THESE CHALLENGES, THE PROCEDURE WAS ABORTED ALTOGETHER. NO FURTHER ATTEMPTS WERE MADE TO RESOLVE THE REPORTED ISSUE, AND THE DECISION WAS MADE TO END THE PROCESS RATHER THAN CONTINUE OR CONVERT TO AN ALTERNATIVE METHOD. CONSEQUENTLY, THE PROCEDURE WAS NOT COMPLETED ROBOTICALLY OR CONVERTED TO ANOTHER ROBOTIC

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 SINGLE PORT (SP) TOTAL COLECTOMY SURGICAL PROCEDURE, THE CUSTOMER ACCESSED A SIDE PORT OF THE SINGLE PORT ACCESS PORT WHEN THE ACCESS PORT TORE CAUSING A LOSS OF INSUFFLATION. THE SURGEON STATED IT WAS TOWARDS THE END OF THE PROCEDURE, AND THEY OPTED TO CONVERT TO AN OPEN SURGICAL PROCEDURE INSTEAD OF REPLACING THE TORN ACCESS PORT. THE PROCEDURE WAS CONVERTED TO OPEN AND COMPLETED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 HYSTERECTOMY PROCEDURE, THE PATIENT WAS TRAPPING CO2 AND HAD TO BE REPOSITIONED TO RESOLVE THE ISSUE. THE ANESTHESIOLOGIST HAD DIFFICULTY OXYGENATING THE PATIENT DUE TO THIS EVENT AND WERE NOT ABLE TO PROPERLY VENTILATE THE PATIENT. THE CUSTOMER REPORTED THAT THEY BELIEVE THIS EVENT WAS CAUSED BY THE DA VINCI INSUFFLATOR EVACUATION PORT. THEY BELIEVED THE PATIENT WAS TRAPPING CO2 AND THAT THE INSUFFLATOR PRESSURE MAY HAVE BEEN PREVENTING THE STAFF FROM OXYGENATING THE PATIENT. THE PATIENT WAS REPORTEDLY FINE POST-OPERATIVELY AND WAS ONLY OBSERVED LONGER THAN PLANNED DUE TO THIS 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 MALIGNANT HYSTERECTOMY PROCEDURE, THE PATIENT WAS TRAPPING CO2 AND HAD TO BE REPOSITIONED TO RESOLVE THE ISSUE. THE ANESTHESIOLOGIST HAD DIFFICULTY OXYGENATING THE PATIENT DUE TO THIS EVENT AND WERE NOT ABLE TO PROPERLY VENTILATE THE PATIENT. THE CUSTOMER REPORTED THAT THEY BELIEVE THIS EVENT WAS CAUSED BY THE DA VINCI INSUFFLATOR EVACUATION PORT. THE CUSTOMER INDICATED THAT THE PATIENT WAS TRAPPING CO2 AND THAT THE INSUFFLATOR PRESSURE MAY HAVE BEEN PREVENTING THE STAFF FROM OXYGENATING THE PATIENT. THE PATIENT WAS REPORTEDLY FINE POST-OPERATIVELY AND WERE ONLY OBSERVED LONGER THAN PLANNED DUE TO THIS 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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLID OFF THE SCISSOR DURING THE CASE AND FELL INTO THE PATIENT. THE MCS TIP COVER ACCESSORY WAS RECOVERED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I AM WRITING IN RELATION TO MY MEDWATCH REPORT (REF: (B)(4)) AND THE ASSOCIATED FDA CDRH CASE REFERENCES (B)(4). I HAVE NOW FINALISED A CONSOLIDATED CROSS-JURISDICTIONAL REGULATORY NOTIFICATION CONCERNING MANUFACTURER-CONTROLLED DATA PATHWAYS AND UNAVAILABLE AUDIT TRAILS WITHIN THE MAKO SMART ROBOTICS SYSTEM, FOLLOWING THE NEW DISCLOSURES ISSUED BY (B)(6) HOSPITALS ON (B)(6) 2025.

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 THE BLADE WAS FOUND BROKEN. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE OR ANYTHING UNUSUAL WAS OBSERVED DURING THE PRE-OPERATIVE CHECK. HOWEVER, DURING THE PROCEDURE, WHILE GRASPING TISSUE, A FRAGMENT OF THE DEVICE FELL INSIDE THE PATIENT. THE SURGEON BELIEVES THAT THE ISSUE MAY HAVE BEEN RELATED TO THE INSTRUMENT'S QUALITY. THE INSTRUMENT HAD BEEN IN USE FOR APPROXIMATELY AN HOUR BEFORE THE PROBLEM OCCURRED, AND SOME FUNCTIONALITY ISSUES WERE NOTICED DURING THE SURGERY, ALTHOUGH THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIALS AT ANY POINT. THE FRAGMENT FELL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION, AND PRIOR TO BREAKAGE, THE INSTRUMENT HAD BEEN REMOVED WITH ITS WRIST STRAIGHTENED; STAFF DID NOT FEEL ANY RESISTANCE DURING REMOVAL. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED AND AGA

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 THE PLACEMENT OF AN 8MM OPTICAL TROCAR FOR A DA VINCI-ASSISTED BENIGN HYSTERECTOMY AND UTEROSACRAL SUSPENSION PROCEDURE, THE PATIENT'S BOWEL AND MESENTERIC VESSELS WERE PUNCTURED UPON ENTRY, NECESSITATING A BOWEL RESECTION. ACCORDING TO THE SURGEON, THE TROCAR PIERCED AN INTRA-ABDOMINAL ADHESION, THE BOWEL, AND MESENTERIC VESSELS. NO TISSUE STICKING OCCURRED, AND THERE WERE NO SYSTEM ERROR MESSAGES OR DEVICE MALFUNCTIONS ASSOCIATED WITH THE EVENT. DUE TO BLEEDING, THE PROCEDURE WAS CONVERTED TO OPEN SURGERY, FOLLOWED BY A BOWEL RESECTION AND BLOOD TRANSFUSION. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PLANNED DA VINCI PROCEDURE WAS NOT PERFORMED. THE PATIENT IS NOW STABLE AND RECOVERING WELL.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, A FRAGMENT FROM THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED WITH ANOTHER FORCEPS INSTRUMENT DURING THE SAME SURGICAL PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. NO X-RAY OR IMAGING WAS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACK-UP HARMONIC ACE INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO POSTOPERATIVE 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 MEDIASTINAL MASS RESECTION PROCEDURE, AN INADVERTENT INJURY TO THE PERICARDIUM OCCURRED WHILE EXCHANGING A FORCEPS INSTRUMENT (SPECIFIC TYPE NOT DISCLOSED). THIS NECESSITATED THE PROCEDURE APPROACH, TO CONVERT TO AN OPEN THORACOTOMY. DETAILS REGARDING THE CAUSE AND TYPE OF INJURY SUSTAINED BY THE PATIENT, THE RESOLUTION OF THE COMPLICATION, AND THE PATIENT'S POSTOPERATIVE STATUS ARE UNKNOWN. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER HOSPITAL FOR REASONS THAT WERE NOT SPECIFIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, 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 HYSTERECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED OFF FROM THE MCS INSTRUMENT AND FELL INSIDE THE PATIENT WHILE PERFORMING THE COLPECTOMY. PRIOR TO USE, BOTH THE INSTRUMENT AND THE ACCESSORY WERE INSPECTED, AND NO DAMAGE OR ABNORMALITIES WERE OBSERVED. THE INSTALLATION TOOL WAS USED PROPERLY; NO PART OF THE ORANGE SURFACE WAS VISIBLE FOLLOWING INSTALLATION, AND THE ACCESSORY WAS NOT INSTALLED BEYOND THE INTENDED POSITION. THE CAUSE OF THE MCS TIP COVER ACCESSORY FALLING INSIDE THE PATIENT REMAINS UNDETERMINED. THE MCS INSTRUMENT WAS REMOVED, AND A THIRD-PARTY LAPAROSCOPIC GRASPER INSTRUMENT WAS USED TO RETRIEVE THE TIP COVER ACCESSORY. THE PELVIS WAS THOROUGHLY INSPECTED, TO CONFIRM THAT NOTHING REMAINED IN THE PATIENT. A NEW MCS TIP COVER ACCESSORY WAS INSTALLED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY. THE PATIENT DID NOT EXPERIENCE ANY POSTOPERATIVE COMPLICATIONS, AND THERE IS NO CONCERN ABOUT THIS EVENT CAUSING ANY LONG-TERM 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, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT, WAS FOUND IN THE PATIENT¿S ABDOMEN AS THEY WERE REMOVING THE SPECIMEN. THE ISSUE OCCURRED WHILE UNDOCKING THE ROBOT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, 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 NON-THORACIC TRANSCERVICAL ESOPHAGECTOMY PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND A FRAGMENT FELL INSIDE THE PATIENT. THIS RESULTED WITH A BRIEF INTERRUPTION OF THE SURGERY AND THE BROKEN PIECE WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

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 PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PATIENT WAS RELEASED ON (B)(6) 2025. NO DEVICE ISSUES WERE 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE NURSE OPENED UP AND USED A SINGLE ACCESS SINGLE PORT KIT. WHEN THE SUTURE WENT THROUGH FINE, A PART OF THE FLAP (YELLOW IN COLOR) POPPED OFF AND FELL INTO THE PATIENT. THE STAFF WAS ABLE TO GET IT OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP COVER SLIPPED OFF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT IN THE MIDDLE OF THE PROCEDURE AND FELL INSIDE THE PATIENT. IT WAS RETRIEVED BY THE ASSISTANT ON THE SPOT. BOTH THE INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE CAREFULLY INSPECTED PRIOR TO USE, AND NO ABNORMALITIES OR DAMAGE WERE DETECTED; THE TIP COVER WAS IN PERFECT CONDITION. THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT, THOUGH NO BREAKAGE WAS OBSERVED AND THE PRECISE REASON FOR IT SLIPPING WAS UNCERTAIN TO THE SURGICAL TEAM. THE ACCESSORY WAS RETRIEVED USING A CLAMP OR SURGICAL INSTRUMENT, AND THERE WAS NO DIFFICULTY OR RESISTANCE UPON REMOVAL THROUGH THE CANNULA; THE INSTRUMENT'S WRIST WAS STRAIGHTENED DURING REMOVAL. DURING USE OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, THERE WERE NO ISSUES WITH THE INSTRUMENT¿S FUNCTIONALITY OR ANY COLLISIONS WITH OTHER DEVICES REPORTED, AND THE TIP COVER APPEARED TO BE CORRECTLY INSTALLED. A REDUCER WAS USED IN THE PROCEDURE. FOLLOWING THE EVENT, THE SURGICAL STAFF NOTED NO DAMAGE TO THE MCS TIP COVER ACCESSORY, INSTRUMENT, OR CANNULA.

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, A FRAGMENT FROM THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT BROKE OFF WHILE THE SURGEON WAS DISSECTING LONG VESSELS. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY USING A BACKUP HARMONIC ACE INSTRUMENT. NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED DUE TO THE FRAGMENT. NO X-RAYS OR IMAGING WAS CONDUCTED. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 PLASTIC PART OF THE TIP BROKE OFF, CAUSING THE MONOPOLAR CURVED SCISSORS (MCS) TIP TO DETACH. A FRAGMENT FELL INTO THE PATIENT AND 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: BOTH THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND ITS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. DURING THIS INSPECTION, THE SURGICAL TEAM NOTED THAT THE SCISSOR TIP WAS SOMEWHAT DIFFICULT TO INSTALL, WHICH WAS UNUSUAL. HOWEVER, NO OVERT PHYSICAL DAMAGE OR IRREGULARITIES WITH THE ACCESSORY OR INSTRUMENT WERE OBSERVED AT THAT TIME. DURING THE PROCEDURE, THE SCISSOR INSTRUMENT WAS USED FOR DISSECTION. AT SOME POINT, THE MCS TIP COVER ACCESSORY/INSTRUMENT TIP FELL INSIDE THE PATIENT. THE TEAM WAS ABLE TO RETRIEVE THE TIP WITH THE AID OF THE INSTRUMENT. WHEN ASKED WHAT MAY HAVE CAUSED THE TIP TO SLIP OFF OR BREAK, THERE WAS NO SPECIFIC INFORMATION PROVIDED BY THE SURGEON. HOWEVER, IT WAS OBSERVED DURING THE CASE THAT THE TIP WAS SEATED CROOKEDLY. THE INSTRUMENT WAS USED FROM

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 INTO TWO PIECES. A FRAGMENT FELL INSIDE THE PATIENT WHILE THE SURGEON WAS SEALING A VESSEL. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY USING A BACKUP HARMONIC ACE INSTRUMENT. NO ADDITIONAL SURGICAL PROCEDURE, SUCH AS LAPAROSCOPY OR OPEN SURGERY, WAS REQUIRED FOR FRAGMENT REMOVAL, AND NO POST-OPERATIVE IMAGING TESTS LIKE X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THERE WAS NO INJURY TO THE PATIENT, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS.

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 TWO SCREWS WERE PLACED AND THE SURGEON NOTED THAT THEY WERE POSITIONED MORE MEDIALLY THAN INTENDED. THIS RAISED CONCERNS ABOUT ALLEGED INACCURACY OF THE GUIDANCE SYSTEM. THE SURGEON PERFORMED A SECOND MEDTRONIC IMAGING SPIN AND TRANSFERRED THE NEW IMAGES TO THE GUIDANCE SYSTEM. BEFORE PLACING A THIRD SCREW, THE SURGEON DECIDED TO ABORT USE OF THE GUIDANCE SYSTEM. ALL SCREWS WERE REMOVED FROM THE PATIENT AND THE GUIDANCE SYSTEM WAS REPLACED WITH A NAVIGATION SYSTEM FOR RE-PLACEMENT OF THE SCREWS. IT WAS NOTED THAT THERE WERE TWO UNUSED STANDARD SPINS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT AND SURGICAL DELAY WAS LESS THAN ONE-HOUR. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TRAJECTORIES WERE NOTED TO DEVIATE BETWEEN 3.5 AND 10 MILLIMETERS (MM) ON ALL THREE OF THE ORIGINALLY PLACED SCREWS, BASED ON MEASUREMENTS FROM THE SECOND COMPLETED MEDTRONIC IMAGING SPIN, MEASURING FROM THE SCREW THAT WAS STILL PLACED AS WELL AS NOTED PATH SEEN ON IMAGING FROM WHERE SCREWS HAD BEEN 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: A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY (NSM) PROCEDURE. THIRTY-SEVEN DAYS AFTER THE INDEX PROCEDURE, THE PATIENT REPORTED A STREAK OF REDNESS ON THE LEFT BREAST. UPON EXAMINATION, AN AREA OF ERYTHEMA WITH MILD BLISTERING ADJACENT TO THE LEFT NIPPLE AREOLA COMPLEX (NAC) WAS NOTED. THE PATIENT IS CURRENTLY ON ANTIBIOTICS AND TAKING AN UNSPECIFIED TOPICAL CREAM FOR A SEROMA. THE EVENT IS ONGOING. DURING THE INDEX PROCEDURE, BILATERAL DRAINS WERE PLACED; THEY WERE REMOVED 19 DAYS AFTER SURGERY. THE BILATERAL SKIN FLAPS WERE VIABLE AT THE END OF THE NSM AND RECONSTRUCTION PROCEDURE; A TWO-STAGE RECONSTRUCTION WAS PLANNED. THERE WERE NO INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS. DISCHARGE OCCURRED TWO DAYS AFTER THE INDEX PROCEDURE. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS DURING THE PROCEDURE. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MILD SEVERITY, NOT A SERIOUS ADVERSE EVENT, A CLAVIEN-DINDO GRADE II, POSSIBLY RELATED TO THE RECONSTRUCTION PROCEDURE, BUT NOT RELATED TO THE DA VINCI SYSTEM, NOT RELATED TO THE NSM PROCEDURE, AND NOT RELATED TO THE PATIENT'S PRE-EXISTING CONDITION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT IN A STUDY UNDERWENT A DA VINCI ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY (NSM) PROCEDURE. THIRTY-SIX DAYS AFTER THE PROCEDURE, THE PATIENT REPORTED FLUID FROM THE LEFT NIPPLE; ANTIBIOTICS WERE PRESCRIBED. THE NEXT DAY, THE PRIMARY INVESTIGATOR DISCUSSED WITH THE PATIENT THAT EXPLANTATION MAY BE REQUIRED IF THE SEROMA CONTINUED. THE EVENT WAS REPORTED AS ONGOING. DURING THE INDEX PROCEDURE, BILATERAL DRAINS WERE PLACED; THEY WERE REMOVED 19 DAYS AFTER THE PROCEDURE. THE BILATERAL SKIN FLAPS WERE VIABLE AT THE END OF THE NSM AND RECONSTRUCTION PROCEDURE; A TWO-STAGE RECONSTRUCTION WAS PLANNED. THERE WERE NO INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS. DISCHARGE OCCURRED TWO DAYS AFTER THE INDEX PROCEDURE. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS DURING THE PROCEDURE. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MILD SEVERITY, NOT A SERIOUS ADVERSE EVENT, A CLAVIEN-DINDO GRADE II, POSSIBLY RELATED TO THE RECONSTRUCTION PROCEDURE, BUT NOT RELATED TO THE DA VINCI DEVICE AND NOT RELATED TO THE NSM PROCEDURE, AND NOT RELATED TO THE PATIENT'S PRE-EXISTING CONDITION.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CONFIRMED THAT THE REPORTED ADVERSE EVENTS WERE RELATED TO THE GUIDANCE SYSTEM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS PLACED SECURELY ON THE MCS INSTRUMENT PRIOR TO USE. WHEN REMOVING THE INSTRUMENT, THE MCS TIP COVER ACCESSORY FELL OFF INSIDE THE PATIENT'S ABDOMEN. THE MCS TIP COVER ACCESSORY WAS REMOVED FROM PATIENT DURING THE SAME SURGICAL PROCEDURE AND A NEW TIP COVER WAS INSTALLED ON THE MCS INSTRUMENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: BOTH THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE, AND NO DAMAGE OR ANYTHING OUT OF THE ORDINARY WAS OBSERVED AT THAT TIME. DURING THE PROCEDURE, THE MCS TIP COVER ACCESSORY WAS RETRIEVED USING THE ASSISTANT PORT AND A LAPAROSCOPIC TOOL. THE SURGEON WAS UNSURE OF WHAT CAUSED THE ACCESSORY TO SLIP OFF OR BREAK AND DID NOT OBSERVE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE TEAM WAS ALSO UNAWARE OF ANY COLLISIONS BETWEEN THE MCS INSTRUMENT AND OTHER INSTRUMENTS DURING THE PROCEDURE. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED

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 WAS FOUND BROKEN ON THE HARMONIC ACE INSTRUMENT. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OOPHORECTOMY SURGICAL PROCEDURE, 68 MINUTES INTO THE PROCEDURE, THE ULTRASONIC SCALPEL TIP SUDDENLY SNAPPED ON THE HARMONIC ACE. THE FIRST ASSISTANT THEN SAFELY RETRIEVED THE INSTRUMENT AND ALL FRAGMENTS UNDER VISUAL INSPECTION. THROUGHOUT THIS PROCESS, THERE WAS NO COLLISION OF THE EQUIPMENT, NOR WAS ANY HARD OBJECT CLAMPED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGICAL INSTRUMENT IN QUESTION WAS INSPECTED PRIOR TO USE, WITH STAFF CONFIRMING THAT THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY OBSERVED - ALL WAS WELL. DURING THE PROCEDURE, THE DEVICE FRAGMENT FELL INSIDE THE PATIENT WHILE THE INSTRUMENT WAS BEING USED FOR GRASPING. THE SURGEON BELIEVES THAT THE BREAKAGE WAS CAUSED BY METAL FATIGUE, AND RECORDS INDICATE THAT THE INSTRUMENT HAD BEEN IN USE FOR 68 MINUTES PRIOR TO THE INCIDENT. NO FUNCTIONAL ISSUES WERE NOTICED BY THE SURGEON DURING THE OPERATION. THE INSTRUMENT WAS NOT REMOVED BEFORE THE BREAKAGE, AND THE WRIST WAS NOT STRAIGHTENED PRIOR TO THAT MOMENT. UPON FINAL REMOVAL OF THE INSTRUMENT AFTER THE E

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS NOT RECOGNIZED. THE STAFF TRIED REPLACING THE HARMONIC ACE INSTRUMENT CORD AND THE CABLE TO THE GENERATOR, BUT THERE WAS NO CHANGE. THE REPORTER FURTHER EXPLAINED THAT THE GENERATOR WAS ALSO SHOWING A RED LED. AS A RESULT, THE SURGEON ELECTED TO CONVERT THE CASE TO OPEN SURGERY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, 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 RADICAL PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) WERE BEING EXCHANGED FOR A LARGE NEEDLE DRIVER WHEN THE MCS TIP COVER ACCESSORY DETACHED AND FELL INTO THE CAVITY. THE MCS WAS REMOVED WITHOUT THE ACCESSORY, WHICH WAS LATER RETRIEVED THROUGH THE LAPAROSCOPIC ASSISTANT PORT. THE INSTRUMENT AND TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE, AND NO DAMAGE WAS NOTED; HOWEVER, THE OPERATING ROOM (OR) STAFF REPORTED MORE RESISTANCE THAN USUAL DURING INSTALLATION. THE ACCESSORY DETACHED DURING INSTRUMENT REMOVAL, AND THE SURGEON BELIEVES THE CAUSE WAS A MALFUNCTION OF THE TIP COVER ACCESSORY. THE MCS INSTRUMENT HAD BEEN IN USE FOR APPROXIMATELY TWO HOURS, AND NO ISSUES WITH ITS FUNCTIONALITY OR COLLISIONS WITH OTHER INSTRUMENTS WERE REPORTED. THE TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED, WITH NO ORANGE SURFACE VISIBLE, NO OVER-INSTALLATION BEYOND THE ORANGE SURFACE, AND THE INSTALLATION TOOL WAS USED. THE ACCESSORY WAS MOISTENED WITH ROOM-TEMPERATURE WATER PRIOR TO INSTALLATION, AND NO REDUCER WAS USED. THERE WERE NO DIFFICULTIES DURING INSTRUMENT REMOVAL, AND THE WRIST WAS STRAIGHTENED UPON REMOVAL

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 DURING AN EXCELSIUSGPS SURGERY A S2AI SCREW WAS PLACED MEDIAL AND INFERIOR. THE NAVIGATION IMAGES SHOWED THAT THE SCREW WAS ON PLAN AND IN THE PROPER PLACE HOWEVER THAT WAS NOT THE CASE. UPON X-RAY IMAGES TO CONFIRM, THE SURGEON NOTICED THAT THE SCREW WAS MEDIAL AND INFERIOR. THE SURGEON REMOVED THE SCREW AND REPLACED THE SCREW IN THE CORRECT SPOT WITHOUT TO USE OF THE ROBOT OR NAVIGATION.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SURGEON DID NOT EXPOSE THE PROXIMAL LUMBAR ANATOMY (L2). WHEN THE MANUFACTURING REPRESENTATIVE (REP) SENT THE ARM TO THE L2 TRAJECTORY, THE SURGEON THOUGHT SHE EXPOSED L2 WHEN IN FACT SHE EXPOSED UP TO L3. SO, SHE SAID THE TRAJECTORY WAS OFF. THEY THEN TOOK AN AP SHOT WITH THE IMAGING SYSTEM TO VERIFY THE EXPOSED LUMBAR ANATOMY. AFTER VERIFICATION, THE SURGEON REALIZED THAT SHE DID NOT EXPOSE L2 AND THAT THE TRAJECTORY WAS CORRECT. ONCE THE ARM WAS SENT TO THE L2 TRAJECTORY AFTER RE EXPOSING THE CORRECT ANATOMY (L2), THE CANNULA WAS PASSED DOWN THE ARM GUIDE AND THE TRAJECTORY IMAGING SHOWED NO DEVIATION. THE SURGEON THEN PLACED THE DRILL FOR THE GUIDANCE SYSTEM DOWN THE GUIDE AND AGAIN THERE WERE NO DEVIATIONS. THE SURGEON THEN PASSED THE DRILL. AFTER DRILLING WITH THE DRILL FOR THE GUIDANCE SYSTEM, THE SURGEON THEN PASSED THE TAP AND AGAIN THERE WERE NO DEVIATIONS. THE REP STATED THAT AFTER LOOKING BACK THROUGH HIS REPORT, THERE WAS NOT AN INITIAL REPORT THAT THERE WAS CLEAR INACCURACY.

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 AN UNSPECIFIED DA VINCI-ASSISTED THORACIC SURGICAL PROCEDURE, THE TIP OF THE SP MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FELL OFF INSIDE THE PATIENT WHILE OPERATING CLOSE TO THE HEART. NO ADDITIONAL SPECIFIC INFORMATION WAS PROVIDED REGARDING THE EVENT. THE FOLLOWING INFORMATION IS UNKNOWN: THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE, IF THE INSTRUMENT TIP WAS RETRIEVED, AND IF THERE WAS ANY ADVERSE OUTCOME TO THE PATIENT DUE TO THE REPORTED ISSUE. THE THORACIC SURGEON EXPRESSED CONCERNS ABOUT THE MCS INSTRUMENT, SPECIFICALLY THE POTENTIAL FOR THE TIP TO DETACH WHEN OPERATING CLOSE TO THE HEART. THE SURGEON HAS THEREFORE SWITCHED TO ONLY USING THE MONOPOLAR SPATULA TIP ON THE MONOPOLAR CAUTERY INSTRUMENT.

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 A SCOPE ISSUE AND DID NOT HAVE ANY ADDITIONAL SCOPES TO CONTINUE THE PROCEDURE. THE PHYSICIAN 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: A GENERAL REPORT WAS RECEIVED THAT DURING AN UNSPECIFIED NUMBER OF DA VINCI-ASSISTED THORACIC SURGICAL PROCEDURES; THE TIPS OF THE SP MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENTS HAD FALLEN OFF WHILE THE SURGEON WAS OPERATING CLOSE TO THE HEART. NO INFORMATION WAS PROVIDED REGARDING ANY SPECIFIC PROCEDURES OR ANY THOUGHTS ON THE NUMBER OF EVENTS THAT MAY HAVE OCCURRED. THE THORACIC SURGEON EXPRESSED CONCERNS ABOUT THE MCS INSTRUMENT, SPECIFICALLY THE POTENTIAL FOR THE TIP DETACHING WHEN OPERATING CLOSE TO THE HEART. THE SURGEON HAS THEREFORE SWITCHED TO ONLY USING THE MONOPOLAR SPATULA TIP ON THE MONOPOLAR CAUTERY INSTRUMENT.

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 DURING A EGPS SURGERY THAT THE SCREW WAS FIGHTING US AS IT ADVANCED. WE DECIDED TO BACK OUT SCREW. THE SCREW WAS FIGHTING US. THERE WAS A STABILIZER FAILURE. THE SURGEON REMOVED POWER BLOCK AND USED T. WE STILL COULDN'T BACK OUT. WE NOTICED STAR TIP OF CUP DRIVER LODGED INTO THE FEMALE STAR OF SCREW. WE REMOVED ROBOT FROM FIELD. WE TOOK AN X-RAY AND THE L4 WAS LOW AND MEDIAL AND NOT IN THE PLANNED TRAJECTORY. THE SURGEON TESTED DRB RIGIDITY WITH FINGERS AND IT WAS COMPLETELY OUT OF BONE. THE SURGEON PROCEEDED TO REMOVE SCREW VIA DRILLING AROUND IT. THE SCREW WAS REMOVED. WE PROCEEDED WITH LAMI/DECOMPRESSION. WE PLACED SCREWS NON ROBOTICALLY POST DECOMPRESSION.

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.

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 A PATIENT WITH A LIGHT OSTEOPOROSIS SUFFERED A FEMORAL FRACTURE 2.5 WEEKS AFTER A TOTAL KNEE ARTHROPLASTY PROCEDURE PERFORMED WITH THE VELYS ROBOTIC ASSISTED SURGERY SYSTEM; THE FRACTURE OCCURRED WHEN SHE STOOD UP FROM A SEATED POSITION, AND THE SURGEON SUSPECTED IT WAS CAUSED BY THE HOLES MADE BY THE VELYS ARRAY PINS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

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 A PATIENT WITH A LIGHT OSTEOPOROSIS SUFFERED A FEMORAL FRACTURE 2.5 WEEKS AFTER A TOTAL KNEE ARTHROPLASTY PROCEDURE PERFORMED WITH THE VELYS ROBOTIC ASSISTED SURGERY SYSTEM; THE FRACTURE OCCURRED WHEN SHE STOOD UP FROM A SEATED POSITION, AND THE SURGEON SUSPECTED IT WAS CAUSED BY THE HOLES MADE BY THE VELYS ARRAY PINS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

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 MCS TIP COVER ACCESSORY FELL INTO A PATIENT. A FRAGMENT WAS RETIRED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 SIGMOID COLECTOMY WITH LOW ANTERIOR RESECTION, THE STAPLER MISFIRED. THE SUREFORM 60 STAPLER WAS FIRED, AND A RESTART MESSAGE APPEARED. THE NURSE CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) MID-PROCEDURE TO REPORT THAT, WHILE FIRING THE STAPLER, A RED SCREEN APPEARED REQUESTING A SYSTEM RESTART DUE TO A POTENTIALLY EXPOSED BLADE. THE SURGEON WAS ABLE TO MANUALLY COMPLETE THE FIRING, AND STAPLES WERE DEPLOYED ACROSS THE BOWEL. PRIOR TO CALLING, THE CUSTOMER HAD ALREADY RESTARTED THE SYSTEM AND REPLACED THE STAPLER WITH A BACKUP. THE PROCEDURE WAS CONTINUING AS PLANNED.

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 MCS TIP COVER ACCESSORY FELL INTO A PATIENT. A FRAGMENT WAS RETIRED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP COVER OF THE SCISSORS WOULD NOT STAY SECURELY ON THE MONOPOLAR CURVED SCISSORS (MCS). THE TIP COVER FELL INSIDE THE PATIENT BUT 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: BOTH THE INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE CAREFULLY INSPECTED PRIOR TO USE, AND NO ABNORMALITIES OR DAMAGE WERE DETECTED; THE TIP COVER WAS IN PERFECT CONDITION. DURING A NEPHRECTOMY, THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT, THOUGH NO BREAKAGE WAS OBSERVED AND THE PRECISE REASON FOR IT SLIPPING REMAINS UNCERTAIN TO THE SURGICAL TEAM. THE ACCESSORY WAS RETRIEVED USING A CLAMP OR SURGICAL INSTRUMENT, AND THERE WAS NO DIFFICULTY OR RESISTANCE UPON REMOVAL THROUGH THE CANNULA; THE INSTRUMENT'S WRIST WAS STRAIGHTENED DURING EXTRACTION. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS IN USE FOR APPROXIMATELY TWO HOURS DURING THE PROCEDURE, DURING WHICH TIME NO ISSUES WITH THE INSTRUMENT¿S FUNCTIONALITY OR ANY COLLISIONS WITH OTHER DEVICES WERE REPORTED, AND THE TIP COVER

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 CYSTECTOMY SURGICAL PROCEDURE, THE SURGEON NOTICED THAT PART OF THE HARMONIC ACE INSTRUMENT SCALPEL PAD HAD COME LOOSE. IMMEDIATE SAFETY TESTING IN A SECURE AREA REVEALED THAT THE PAD HAD COMPLETELY DETACHED. ALL FRAGMENTS AND THE INSTRUMENT WERE SUBSEQUENTLY RETRIEVED UNDER DIRECT VISUAL INSPECTION. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS THOROUGHLY INSPECTED PRIOR TO USE, AND NO DAMAGE OR ABNORMALITIES WERE OBSERVED; IT APPEARED TO BE IN NORMAL WORKING CONDITION WHEN THE SURGICAL PROCEDURE BEGAN. DURING THE OPERATION, THE INCIDENT OCCURRED WHILE THE INSTRUMENT WAS BEING USED FOR GRASPING TISSUE. THE SURGEON BELIEVES THE FRAGMENT ISSUE WAS POTENTIALLY CAUSED BY THE GASKET FALLING OUT DUE TO A COMBINATION OF THE HIGH TEMPERATURE OF THE JAWS (WHICH MAY HAVE SOFTENED THE GASKET) AND THE MECHANICAL STRESSES FROM CLAMPING AND PULLING TISSUE. THE INSTRUMENT HAD BEEN IN USE FOR APPROXIMATELY 74 MINUTES BEFORE THE ISSUE AROSE. THROUGHOUT THE SURGICAL PROCEDURE, THE INSTRUMENT FUNCTIONED AS EXPECTED WITH NO REP