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 SINGLE PORT (SP) DA VINCI-ASSISTED NIPPLE-SPARING MASTECTOMY (NSM) SURGICAL PROCEDURE, THERE WAS A CONVERSION BACK TO OPEN (THE PROCEDURE HAD BEGUN OPEN) TO ADDRESS EXCESSIVE BLEEDING AT THE MEDIAL EDGE OF THE BREAST DUE TO PATIENT ANATOMY AND FOR USER EFFICIENCY. THIS CONVERSION WAS ALREADY ANTICIPATED AS A FEASIBLE AND EXPECTED ALTERNATIVE. THE PROCEDURE WAS DESIGNED TO COMBINE BOTH OPEN AND ROBOTIC TECHNIQUES. THE EXACT AMOUNT OF BLOOD LOST IS UNKNOWN, BUT INTERVENTIONS TO CONTROL THE BLEEDING INCLUDED THE USE OF FLOSEAL, BIPOLAR COAGULATION WITH SP FENESTRATED BIPOLAR, AND LIGASURE DURING THE OPEN PROCEDURE. NO BLOOD TRANSFUSIONS WERE ADMINISTERED.

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). AT THE 42-DAY FOLLOW-UP, A NEUROPATHY WAS REPORTED. THE EVENT ONSET DATE HAS BEEN REPORTED AS POST-OPERATIVE DAY #14. THE NEUROPATHY WAS LOCATED BILATERALLY, IN THE RIGHT AND LEFT BREASTS. THE NEUROPATHY PAIN WAS IDENTIFIED BY THE PATIENT AND REPORTED TO THE PLASTICS TEAM THAT SHE WAS UNABLE TO GET AHEAD OF THE PAIN IN HER BREASTS AND ASKED FOR RELIEF. IT WAS DESCRIBED AS "PERSISTENT, SEARING PAIN LOCALIZED TO THE BREAST AREA ABOVE THE NIPPLE AND INCISION LINE, WHICH WORSENS WITH ACTIVITY. THE PAIN IS CONSTANT, NON-RADIATING, AND NOT ASSOCIATED WITH INCISIONAL SITES. THE SKIN IS NUMB, AND ACTIVITIES SUCH AS WALKING OR CAR RIDES EXACERBATE THE PAIN. THE PAIN DOES NOT RADIATE AROUND THE CHEST WALL, ARMS, OR LEGS." THE TISSUE EXPANDERS WERE REPORTED AS UNCOMFORTABLE BUT NOT ATTRIBUTED TO THE CURRENT PAIN. TREATMENT CONSISTED OF REFERRAL TO A PAIN CLINIC AND PRESCRIPTIONS FOR IBUPROFEN, TYLENOL, DICLOFENAC AND GABAPENTIN. A BILATERAL PECS I/II BLOCK IN-CLINIC PROCEDURE WAS SCHEDULED; HOWEVER, THE PATIENT INDICATED THAT THE PRESCRIBED MEDICATIONS HAD RELIEVED THE PAIN AND CANCELED THE NERVE BLO

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 BILATERAL NIPPLE-SPARING MASTECTOMY PROCEDURE, THE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR DISPLAYED MONOPOLAR ENERGY SHIELD ERRORS. DESPITE REPLACING THE MONOPOLAR CABLE AND GROUNDING PAD, THE ERROR MESSAGES PERSISTED. THE IESU ALSO FAILED WHEN USED WITH A HANDHELD BOVIE PEN. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONSULTED AND RECOMMENDED A HARD RESTART OF THE DEVICE; HOWEVER, THE ERRORS CONTINUED. WITH NO BACKUP IESU AVAILABLE AT THE FACILITY, THE SURGEON DECIDED TO CONVERT THE CASE TO OPEN SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF AN ARTICLE THAT EVALUATED THE PERIOPERATIVE, ONCOLOGIC, AND FUNCTIONAL OUTCOMES OF PATIENTS WITH RECURRENT OROPHARYNGEAL SQUAMOUS CELL CARCINOMA TREATED WITH TRANSORAL ROBOTIC SURGERY (TORS) AND SUBMENTAL FLAP RECONSTRUCTION WAS PERFORMED. THE STUDY RETROSPECTIVE COHORT DESIGN ANALYZED 8 PATIENTS UNDERGOING SALVAGE TRANSORAL ROBOTIC SURGERY (TORS) WITH SUBMENTAL ISLAND FLAP RECONSTRUCTION BETWEEN DECEMBER 2019 AND FEBRUARY 2024. TWO PATIENTS WERE READMITTED TO THE HOSPITAL POSTOPERATIVELY, ONE WITH FAILURE TO THRIVE AND DEHYDRATION 6 DAYS AFTER DISCHARGE, AND THE OTHER DUE TO ALTERED MENTAL STATUS 8 DAYS AFTER DISCHARGE. ONE PATIENT HAD A NECK HEMATOMA DURING THEIR HOSPITAL ADMISSION ON POSTOPERATIVE DAY 1 THAT NECESSITATED INCISION AND DRAINAGE. PER THE AUTHOR, NO COMPLICATIONS WERE RELATED TO THE ISI DEVICE.

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.

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 DISTAL SUBTOTAL GASTRECTOMY SURGICAL PROCEDURE, THERE WAS NO OCCURRENCE OF INSTRUMENT COLLISION, BUT THE METAL SHEET OF THE HARMONIC ACE CUTTER HEAD BROKE. THE BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT'S BODY, CAUSING NO DAMAGE TO THE PATIENT. THE SUBSEQUENT SURGERY WAS COMPLETED USING A NEW INSTRUMENT. 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 SUBTOTAL GASTRECTOMY SURGICAL PROCEDURE, THE FRONT END OF THE HARMONIC ACE INSTRUMENT WAS FRACTURED. THE FRACTURED PART WAS COMPLETELY REMOVED, AND NO FRAGMENT REMAINED IN 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 SUBTOTAL GASTRECTOMY PROCEDURE, THE FRONT END OF THE HARMONIC ACE INSTRUMENT FRACTURED AND A FRAGMENT FELL INSIDE THE PATIENT. THE PROCEDURE 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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

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 FRONT END OF THE HARMONIC ACE INSTRUMENT FRACTURED AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE CUSTOMER USED A BACKUP HARMONIC ACE INSTRUMENT TO COMPLETE THE PROCEDURE 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 PANCREATODUODENECTOMY PROCEDURE, THE FRONT END OF THE HARMONIC ACE INSTRUMENT FRACTURED AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. A BACKUP HARMONIC ACE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE 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: 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 PANCREATODUODENECTOMY PROCEDURE, THE FRONT END OF THE HARMONIC ACE INSTRUMENT FRACTURED AND FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. A BACKUP HARMONIC ACE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE 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 NEPHRECTOMY SURGICAL PROCEDURE; THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL IN THE PATIENT. THE TIP COVER WAS RETRIEVED DURING THE SAME PROCEDURE. THERE WAS NO ADDITIONAL HARM TO THE PATIENT. THE TIP COVER IS NOT AVAILABLE FOR RETURN. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE NO DAMAGE WAS OBSERVED. THE MCS TIP COVER ACCESSORY WAS OBTAINED DURING STERILIZATION PROCESS (IT WAS NOT PREVIOUSLY REPROCESSED). THE FRAGMENT FELL INSIDE OF THE PATIENT DURING THE INSTRUMENT REMOVAL THROUGH THE TROCAR. THE SURGEON BELIEVES THERE WAS FRICTION BETWEEN THE CUFF OF THE SCISSORS AND THE TROCAR. THE INSTRUMENT WAS USED THE ENTIRE PROCEDURE FOR APPROXIMATELY 3.5 HOURS. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT DURING THE SURGICAL PROCEDURE. THE MCS TIP COVER WAS PROPERLY INSTALLED BY AN EXPERIENCED OPERATING ROOM NURSE. NO ORANGE SURFACE WAS VISIBLE AFTER 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE FRONT END OF THE HARMONIC ACE INSTRUMENT WAS FRACTURED. IT WAS CONFIRMED THAT THE FRACTURED PART HAS BEEN COMPLETELY REMOVED, AND NO FRAGMENT REMAINED IN 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 WOUND PROTECTOR FOR THE ADVANCED ACCESS PORT REQUIRED TO BE SUTURED TO THE PATIENT'S DIAPHRAGM AND CHEST WALL IN ORDER TO MAINTAIN THE DESIRED PLACEMENT AND SECUREMENT TO PROCEED WITH THE CASE. THE SURGEON STATED THIS TASK TOOK AN ADDITIONAL 50 MINUTES. THE PROCEDURE WAS COMPLETED ROBOTICALLY AS PLANNED WITH NO REPORTED PATIENT INJURY.

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 MALIGNANT WITH RECONSTRUCTION NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP WAS SEPARATED FROM THE INSTRUMENT DURING THE PROCEDURE. THE METAL PART AND PLASTIC PART WAS SEPARATED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CLARIFIED THAT THE SCISSORS TIP ACCESSORY DID FALL INTO THE PATIENT AND WAS RETRIEVED. THE METAL SCISSORS WERE SEPARATED FROM THE PLASTIC COVER OF THE TIP ACCESSORY. THE CUSTOMER DID NOT OBSERVE ANY DAMAGE ON THE SP MONOPOLAR CURVED SCISSOR TUBE ADAPTER AND USED ANOTHER SCISSORS TIP ACCESSORY TO CONTINUE 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: 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 LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED UNSTABLE ENERGY OUTPUT WITH A HARMONIC ACE INSTRUMENT. AS A RESULT, THE CUSTOMER ELECTED TO CONVERT THE CASE TO TRADITIONAL LAPAROSCOPIC SURGERY AND AN ADDITIONAL INCISION WAS PLACED.

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

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 PARTIAL RESECTION PROCEDURE, THE CUSTOMER RECEIVED A "REDUCE TIP PRESSURE" MESSAGE WHILE USING A HARMONIC ACE INSTRUMENT. THE INSTRUMENT THEN SUDDENLY BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED 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: A clinical study article reported a retrospective single-center study of consecutive children under 12 months of age who underwent robotic surgery between 2010 and 2020. All procedures were performed using the da Vinci Si surgical system.Postoperative complications were reported in 6 patients, 2 of whom required reoperation. These complications included partial dehiscence of an anorectal anastomosis due to surgical wound infection requiring redo surgery, ileus, accidental gastrostomy outlet requiring endoscopic placement, pleural effusion, bradycardia, and atelectasis.The authors concluded that robotic surgery in newborns and infants can be considered feasible and safe when performed by well-trained surgeons. They also suggested that a wide range of procedures, including complex surgeries in small children, can be carried out safely with a very low complication rate. It was recommended that, further multicenter studies are needed to validate these findings.Intuitive Surgical Inc. (ISI) has made multiple attempts to obtain additional information; however, as of the date of this report, no new information has been obtained.

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 (MSC) TIP COVER ACCESSORY, INSTALLED ON AN MCS INSTRUMENT, FELL OFF INSIDE THE PATIENT. IT IS UNKNOWN IF THE MCS TIP COVER ACCESSORY WAS RETRIEVED. 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER PARTIAL RESECTION PROCEDURE, THE HARMONIC ACE INSTRUMENT SUDDENLY BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL 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 SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE, AND A FRAGMENT FELL INSIDE THE PATIENT WHILE THE SURGEON WAS GRASPING TISSUE. THE SURGEON SUSPECTED IT MAY HAVE BEEN A QUALITY ISSUE. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED BY THE ASSISTANT USING ANOTHER INSTRUMENT, AND VISUAL CONFIRMATION ENSURED THAT NO FRAGMENTS REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACKUP HARMONIC ACE INSTRUMENT, AND THERE WERE NO POST-SURGICAL COMPLICATIONS REPORTED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED, AND NO POST-OPERATIVE TESTING WAS PERFORMED.

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 performed that presented a retrospective review of experiences with robotic-assisted segmentectomy procedures for early-stage non-small-cell lung cancer. The article noted 1 patient who experienced severe pulmonary embolism (grade IV) and one patient experienced sputum retention requiring bronchoscopy (grade IIIa). No device malfunctions were reported, and the authors did not report any events caused by any Intuitive Surgical, Inc. (ISI) device. The corresponding author was contacted but no response has been received.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE DUE TO ONGOING ISSUES WITH STERILE ADAPTERS. NO TROUBLESHOOTING WAS PERFORMED AS THE SURGEON INSTRUCTED THE OR STAFF TO END THE CALL WITH THE TSE. AT THE TIME THE EVENT OCCURRED, ANESTHESIA WAS ALREADY ADMINISTERED TO THE PATIENT AND PORTS WERE PLACED. IT IS UNCLEAR IF THE CASE WAS ABORTED OR CONVERTED TO OPEN SURGERY.

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 PROSTATECTOMY PROCEDURE, A PIECE OF RUBBER WAS FOUND IN THE SURGICAL FIELD AND REMOVED. THE EVENT OCCURRED AFTER THE CAMERA WAS DOCKED AND INSTRUMENTS WERE INSERTED. UPON EXAMINATION, IT WAS CONFIRMED THAT THE RUBBER INSIDE THE UNIVERSAL SEAL WAS TORN. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE AND WAS CONFIRMED TO BE COMPLETELY REMOVED THROUGH VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURES WERE REQUIRED, NOR WERE ANY POST-OPERATIVE TESTS SUCH AS X-RAYS OR ULTRASOUNDS CONDUCTED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT THE NEED FOR A BACKUP UNIVERSAL SEAL. MOREOVER, THE PATIENT HAS NOT HAD TO RETURN TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE BROKE. A FRAGMENT FELL INSIDE 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. THE NURSE DIDN'T REMEMBER EXACTLY WHAT SURGICAL TASK WAS PERFORMED AT THAT TIME OF THE DEVICE FRAGMENT FALLING INSIDE OF THE PATIENT, BUT THE ISSUE DID NOT OCCUR WHILE INSERTING OR REMOVING THE INSTRUMENT. IT IS UNKNOWN WHAT THE SURGEON BELIEVED WAS THE CAUSE OF THE INSTRUMENT BREAKAGE. THE INSTRUMENT WAS IN USE FOR ABOUT AN HOUR, AND THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE FRAGMENT DID NOT FALL INSIDE OF THE PATIENT DURING AN INSTRUMENT TIP/ ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE SURGICAL PROCEDURE PRIOR TO THE BREAKAGE. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED. 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE WHITE PIECES OF THE INSIDE OF THE JAW OF SYNCHROSEAL WERE FALLING OFF INTO THE PATIENT DURING THE CASE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE SURGICAL TASK BEING PERFORMED AT THE TIME THE DEVICE FRAGMENT FELL INSIDE THE PATIENT WAS DISSECTION. IT IS UNKNOWN WHAT THE SURGEON BELIEVED WAS THE CAUSE OF THE INSTRUMENT BREAK OR THE FRAGMENT FALLING INSIDE THE PATIENT. IT IS UNKNOWN HOW LONG THE INSTRUMENT HAD BEEN USED PRIOR TO THE ISSUE. THE SURGEON NOTICED THAT PIECES WERE FALLING OFF INTO THE PATIENT DURING THE PROCEDURE. IT IS UNKNOWN IF THE INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS REMOVED DURING THE SURGICAL PROCEDURE PRIOR TO THE BREAKAGE, WITH THE WRIST STRAIGHTENED. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED. THE STAFF DIDN'T FEEL ANY RE

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 SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE, AND A FRAGMENT FELL INSIDE THE PATIENT WHILE THE SURGEON WAS GRASPING TISSUE. THE SURGEON SUSPECTED THERE MAY HAVE BEEN A QUALITY ISSUE. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED BY THE ASSISTANT USING ANOTHER INSTRUMENT, AND VISUAL CONFIRMATION ENSURED THAT NO FRAGMENTS REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACKUP HARMONIC ACE INSTRUMENT, AND THERE WERE NO POST-SURGICAL COMPLICATIONS REPORTED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED, AND NO POST-OPERATIVE TESTS WERE PERFORMED.

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 AT THE END OF A DA VINCI-ASSISTED PYELOPLASTY PROCEDURE AND AFTER ALL THE INSTRUMENTS WERE TAKEN OUT, A SEAL FROM A ACCESS PORT KIT SNAPPED AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED WITH A GRASPER AND WAS PULLED OUT THROUGH THE EXISTING PORT INCISION. THE PATIENT DID NOT HAVE ANY COMPLICATIONS DUE TO THIS SITUATION AND IS DOING WELL IN POSTOPERATIVELY.

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.

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 SURGICAL PROCEDURE, A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY, INSTALLED ON AN MCS INSTRUMENT, FELL OFF INSIDE THE PATIENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED AND REPLACED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. THE CUSTOMER WAS UNABLE TO PROVIDED ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT SUCH AS THE EVENT DATE. NO PRODUCT WILL BE RETURNED.

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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, USER REPORTED THAT THERE WERE CHALLENGES WITH THE USE OF THE CUSTOM REMOTE CENTER (CRC) FEATURE, WHICH CREATED UNNECESSARY STRESS FOR THE STAFF AND POSED INTRAOPERATIVE CHALLENGES WHILE OPERATING NEAR THE PARENCHYMAL WALL. PARENCHYMA WALL. THERE WAS NO INJURY OR BLEEDING DUE TO THIS AT ALL. THE USER NOTED THAT THERE WERE NO ISSUES WITH THE SYSTEM ITSELF, BUT THE DIFFICULTIES WITH THE CRC LED TO IT BEING DISABLED. HOWEVER, BY THAT POINT, THE SURGEON HAD ALREADY DECIDED TO CONVERT THE CASE TO OPEN. THE USER EXPRESSED A DESIRE FOR THE CRC FEATURE TO BE MORE USER-FRIENDLY TO PREVENT SUCH COMPLICATIONS IN THE FUTURE. THE REPORTER CONFIRMED THAT THE PROCEDURE WAS CONVERTED TO OPEN DUE TO FRUSTRATION WITH THE CUSTOM REMOTE CENTER (CRC) 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL SALVAGE PROSTATECTOMY PROCEDURE, MONOPOLAR ENERGY CEASED TO FUNCTION, ACCOMPANIED BY AN ERROR. EACH ATTEMPT BY THE CUSTOMER TO APPLY MONOPOLAR ENERGY RESULTED WITH THE ERROR. THE NURSE MENTIONED THAT BIPOLAR ENERGY REMAINED UNAFFECTED. AS A WORKAROUND, AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) SUGGESTED CONNECTING A FORCE TRIAD GENERATOR WITH AN EXTERNAL PEDAL TO GENERATE MONOPOLAR ENERGY. THE NURSE CONFIRMED THE PRESENCE OF THE BACKUP GENERATOR BUT NOTED THAT THE SURGEON DECIDED TO ABORT THE PROCEDURE. AT THE TIME THE CASE WAS ABORTED, ANESTHESIA HAD ALREADY BEEN ADMINISTERED TO THE PATIENT AND PORTS HAD BEEN PLACED.

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

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 AFTER PORT PLACEMENT THE TEAM HAD PREPARED A PATIENT FOR A RADICAL EXTRAPERITONEAL PROSTATECTOMY. THE SURGEON, AFTER MAKING THE INITIAL INCISION, INSERTED THE SINGLE PORT (SP) ACCESS PORT INTO THE PATIENT. HOWEVER, WHEN ATTEMPTING TO DOCK THE SP SYSTEM, AN ERROR MESSAGE APPEARED INDICATING THAT THE "CANNULA WAS INVALID." FOLLOWING THE TECHNICAL SUPPORT ENGINEER'S (TSE) RECOMMENDATION, THE TEAM OPENED A SECOND SMALL ACCESS PORT KIT, BUT IT RESULTED IN THE SAME ERROR MESSAGE. A HARD SYSTEM RESTART DID NOT RESOLVE THE ISSUE, SO THE TEAM UNDOCKED THE SP, RE-DRAPED THE SYSTEM, AND ATTEMPTED TO REDOCK, BUT THE ERROR PERSISTED. WITH ADVICE FROM THE TSE, AN ENGINEER VISIT WAS SCHEDULED, CONTINGENT ON RECEIVING SPARE PARTS FROM THE NETHERLANDS. THE PROCEDURE WAS CONVERTED TO A MULTI-PORT DA VINCI XI SYSTEM TO COMPLETE THE PROCEDURE. THE CUSTOMER HAD TO CLOSE THE INITIAL SINGLE ACCESS PORT INCISION THAT WAS MADE ON THE PATIENT AND PUT 4 ADDITIONAL 8MM CANNULAS IN FOR THE XI CASE, WHICH MEANT A DIFFERENT APPROACH WAS USED FOR THE CASE AND NOT THE PLANNED EXTRAPERITONEAL APPROACH. THE TRANSITION TO THE XI SYSTEM AND THE TROUBLESHOOTING EFFORTS CAUSED A DELAY OF APPROXIMATELY 45

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 reported one case of pelvic infection with effusion (Clavien-Dindo grade IIIa) occurred postoperatively, followed by ultrasound under local anesthesia improvement after guided puncture and drainage with tube placement.

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 SLID OFF. THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED TECHNICAL SUPPORT TO REPORT THAT THE MCS TIP COVER WAS SLIDING UPWARDS WHEN REMOVING THE INSTRUMENT. THE CSR ASKED IF THE MCS TIP COVER WOULD SHOW UP ON X-RAY. THE TECHNICAL SERVICE ENGINEER (TSE) INFORMED THE CSR THAT THE MCS TIP COVER IS RADIOLUCENT. THE TSE RECOMMENDED THE SITE CALL BACK IN IF THEY REQUIRE ADDITIONAL ASSISTANCE OR HAVE ANY FURTHER INFORMATION TO PROVIDE. 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: REFER TO H11 FOR FOLLOW-UP INFORMATION.