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 CYSTECTOMY PROCEDURE, A SMALL METAL FRAGMENT FROM A SYNCHROSEAL INSTRUMENT WAS FOUND IN THE PATIENT'S ABDOMEN. THE SURGEON WAS ABLE TO REMOVE THE FRAGMENT 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 SYNCHROSEAL INSTRUMENT WAS IN USE FOR APPROXIMATELY ONE HOUR AND 30 MINUTES BEFORE THE EVENT OCCURRED. THERE WERE NO ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS, OR HARD MATERIAL. THE REPORTER DID NOT SEE WHEN THE FRAGMENT DETACHED BUT MENTIONED THAT IT WAS FOUND IN THE PATIENT'S INTESTINE. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. NO DAMAGE WAS NOTED TO THE CANNULA AFTER THE EVENT. THE FRAGMENT WAS REMOVED WITH A FORCEPS INSTRUMENT BY THE OPERATING ASSISTANT. ALL FRAGMENTS WERE RETRIEVED AND NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. NO POST-OPERATIVE TESTS LIKE AN X-RAY, OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PATIENT HAS N

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 sacrocolpopexy procedures. The article compared the outcomes of patients who underwent robotic sacrocolpopexy with (HYST) or without supracervical hysterectomy (no-HYST) group. In the no-HYST group, a number of patients experienced the following complications: One abdominal wall hematoma, one case of ileus, one patient requiring self-catheterization, one reporting pain, one case of occlusive syndrome due to constipation that resolved with medical treatment, and one abdominal wall abscess.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: 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 FROM THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE USER COMPLETED THE PROCEDURE USING A BACKUP HARMONIC ACE INSTRUMENT WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

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

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: A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI ASSISTED NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED ADVERSE EVENTS OR DA VINCI DEVICE MALFUNCTIONS. IT WAS REPORTED THAT RIGHT BREAST LATERAL FIRMNESS DEVELOPED WITHIN THE FIRST 24 HOURS. ON POST-OPERATIVE DAY ONE, THE PATIENT RETURNED TO THE OPERATING ROOM (OR) FOR RIGHT BREAST HEMATOMA WASHOUT AND EVACUATION. THE PROCEDURE WAS TOLERATED WELL. PROLONGED HOSPITALIZATION WAS REQUIRED, AND THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY TWO. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MILD SEVERITY, A CLAVIEN-DINDO GRADE III, POSSIBLY RELATED TO THE STUDY PROCEDURE, POSSIBLY RELATED TO THE RECONSTRUCTION PROCEDURE, BUT NOT RELATED TO THE DA VINCI STUDY DEVICE, 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATICODUODENECTOMY PROCEDURE, THE CUSTOMER ENCOUNTERED A "REDUCE TIP PRESSURE" MESSAGE WHILE USING A HARMONIC ACE INSTRUMENT. A NURSE TOOK OUT THE INSTRUMENT, NOTED THAT THE INSTRUMENT WAS INTACT, AND THEN WIPED ADHERED TISSUE AT THE TIP OF THE INSTRUMENT WITH A GAUZE. AFTER REINSTALLING THE HARMONIC ACE INSTRUMENT, THE CUSTOMER NOTICED THAT THE TIP OF THE HARMONIC ACE BROKE AND A FRAGMENT HAD FALLEN INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH 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 SURGICAL PROCEDURE, WHEN THE CAP WAS USED WITH THE INSTRUMENT, A BLACK PIECE WAS OBSERVED INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WITH A DELAY OF GREATER THAN 30 MINUTES. THERE WAS UNCERTAINTY ABOUT WHICH OF THE UNIVERSAL SEALS WERE INVOLVED, LEADING TO THE DECISION TO RETURN ALL THREE SEALS FOR FURTHER INVESTIGATION. 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 THYROIDECTOMY PROCEDURE, THE PATIENT SUSTAINED A BURN WHILE THE 30-DEGREE ENDOSCOPE PLUS CAMERA WAS IN USE. THE FOLLOWING INFORMATION IS UNKNOWN: THE CAUSE OF THE BURN INJURY, WHAT TISSUE WAS SPECIFICALLY BURNED, THE SEVERITY OF THE BURN, AND WHAT MEDICAL INTERVENTION (IF ANY) WAS RENDERED DUE TO COMPLICATION. THE PROCEDURE WAS COMPLETED ROBOTICALLY. ADDITIONAL INFORMATION WAS REQUESTED, BUT THE CUSTOMER HAS INDICATED THAT NO FURTHER INFORMATION WILL BE 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, THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) TIP KEPT FALLING FROM THE MCS INSTRUMENT. THE MCS TIP 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 WAS NOTED. THE SURGEON BELIEVED THE INSTRUMENT WAS DAMAGED DURING THE SURGERY; IT WAS USED FOR 5 MINUTES. THE SURGEON NOTICED THAT THE TIP HAD DROPPED. INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR THE HARDWARE MATERIAL DURING THE SURGICAL PROCEDURE. THE FRAGMENT DIDN'T FALL INSIDE OF THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE. UPON FINAL REMOVAL OF THE INSTRUMENT THE WRIST WAS STRAIGHTENED. NO DAMAGE WAS NOTED TO THE INSTRUMENT, OR THE CANNULA UPON FINAL REMOVAL. HOWEVER, THE SURGICAL STAFF NOTICED THAT THE CONNECTOR OF THE INSTRUMENT WAS DAMAGED. THE ASSISTANT RETRIEVED ALL FRAGMENTS AND CONFIRMED THAT NOTHING WAS LEFT BEHIND. NO ADDITIONA

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, THE JAW OF A GRASPER INSTRUMENT BROKE. THE CUSTOMER WANTED TO KNOW IF THE GRASPER INSTRUMENT WAS RADIOPAQUE. IT IS UNCLEAR WHEN THE DEVICE ISSUE WAS IDENTIFIED. THE FOLLOWING INFORMATION IS UNKNOWN: THE PROCEDURE NAME, THE SPECIFIC INSTRUMENT NAME, THE INSTRUMENT'S PART AND LOT #S, WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE INSTRUMENT BROKE, IF A FRAGMENT BROKE OFF THE INSTRUMENT AND FELL INSIDE THE PATIENT, IF THERE WAS ANY INJURY TO THE PATIENT, AND THE PROCEDURE 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 SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE. A FRAGMENT 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: 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: 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: 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 HARMONIC ACE COULD NOT BE RECOGNIZED, INDICATING THAT THE HEAD PRESSURE WAS TOO HIGH, AND THE OPERATION WAS CONTINUED WITH A NEW HARMONIC ACE. THE MAIN SURGEON HAS EXTENSIVE SURGICAL EXPERIENCE AND THERE WERE NO ERRORS IN OPERATION OR EXCESSIVE TISSUE CLAMPING. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT HEAD END WAS DAMAGED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. A GENERAL HEPATO-PANCREATO-BILIARY (HPB) PROCEDURE WAS BEING PERFORMED WHEN THE ISSUE OCCURRED. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER TOOLS DURING THE PROCEDURE. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE INSTRUMENT IS AVAILABLE FOR RETURN TO ISI FOR ANALYSIS. THE FRAGMENT OF THE INSTRUMENT HEAD END WAS COMPLETELY DETACHED FROM THE INSTRUMENT.

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: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WERE TWO INSTANCES WHERE A UNIVERSAL SEAL TORE AND FRAGMENTS DETACHED. IT IS UNCLEAR IF ANY FRAGMENTS FELL INSIDE THE PATIENT. 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 NURSE INDICATED THAT THE IMAGE WAS FLICKERING. THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) FOR ASSISTANCE. THE TSE GUIDED THE CUSTOMER WITH RESEATING THE ENDOSCOPE. THE CUSTOMER STATED THAT HE HAD TRIED THAT BUT THE ISSUE REMAINED. THE TSE THEN GUIDED THE CUSTOMER WITH REPLACING THE ENDOSCOPE. THE CUSTOMER REPLIED THAT THERE WERE LOTS OF PROCEDURES TODAY AND HE WAS NOT ABLE TO TRY A BACKUP ENDOSCOPE. THE PROCEDURE WAS 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: A REVIEW OF A LITERATURE ARTICLE TITLED: "PROS AND CONS OF DA VINCI CURVED-TIP STAPLER HOSPITAL: MINAMI TOHOKU GENERAL HOSPITAL, DEPARTMENT OF THORACIC SURGERY" WAS PERFORMED. THE ARTICLE DISCUSSED A DA VINCI-ASSISTED RIGHT UPPER LOBECTOMY PROCEDURE PERFORMED ON A 85-YEAR-OLD-FEMALE PATIENT. WHEN DISSECTING THE UPPER AND LOWER LOBES, A SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT, WITH A GREEN SUREFORM 45 RELOAD INSTALLED, WAS INSERTED AFTER PASSING A PENROSE DRAIN BETWEEN THE LOBES. THE SURGEON THOUGHT THE STAPLER INSTRUMENT SLID DIRECTLY ABOVE THE PENROSE DRAIN, BUT THE TIP OF THE STAPLER INSTRUMENT HAD PIERCED THE LUNG. THERE WAS NO BLEEDING OBSERVED, SO THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT WAS INSERTED AGAIN AND USED TO DISSECT THE REMAINING LOBES. THE FOLLOWING INFORMATION IS UNKNOWN: IF LUNG TISSUE WAS ACTUALLY INJURED/DAMAGED AND WHAT MEDICAL INTERVENTION (IF ANY) WAS RENDERED DUE TO THE COMPLICATION. THE ARTICLE MENTIONED THAT SURGEONS SHOULD PAY ATTENTION TO THE DIRECTION OF THE STAPLER INSTRUMENT'S TIP AND THAT CARE MUST BE TAKEN WHEN THE FIELD OF VIEW IS POOR, DISSECTION IS INSUFFICIENT, OR THE BLOOD VESSELS BRANCH. THE AUTHORS CONCLUDED THAT THE TIP OF THE ANVIL O

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 ROBOTIC HELLER MYOTOMY, A FRAGMENT DETACHED FROM THE CANNULA SEAL AND FELL INSIDE THE PATIENT. THERE WAS UNCERTAINTY ABOUT ITS ORIGIN, WHETHER IT WAS FROM THE PRODUCT ITSELF OR ALREADY PRESENT IN THE TROCAR DUE TO PACKAGING OR MANUFACTURING. THE FRAGMENT WAS RETRIEVED USING A MARYLAND INSTRUMENT VIA THE ASSIST PORT, BUT THERE WAS UNCERTAINTY ABOUT THE COMPLETENESS OF THE RETRIEVAL DUE TO THE SMALL SIZE OF THE FRAGMENTS, WHICH MEASURED APPROXIMATELY 2MM X < 1MM. NO ADDITIONAL SURGICAL PROCEDURES WERE NECESSARY TO REMOVE THE FRAGMENT, AND NO POST-OPERATIVE TESTS LIKE X-RAYS OR ULTRASOUNDS WERE CONDUCTED TO VERIFY THE PRESENCE OF REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY, AND THERE HAS BEEN NO HOSPITAL RETURN DUE TO POST-SURGICAL COMPLICATIONS RELATED TO RETAINING FOREIGN OBJECTS.

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 THE ARTICLE REPORTED THE FOLLOWING ADVERSE EVENT. ONE PATIENT EXPERIENCED UNEXPLAINED CHEST PAIN, INITIALLY SUSPECTED TO BE RELATED TO CORONARY SYNDROME, BUT NO SIGNIFICANT ABNORMALITIES WERE OBSERVED ON CORONARY ANGIOGRAPHY. AT THE 1-MONTH FOLLOW-UP, THE PATIENT WAS FOUND TO HAVE A MODERATE PLEURAL EFFUSION, TREATED WITH THORACIC PUNCTURE AND CATHETER DRAINAGE.

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 PROSTATE PROCEDURE, THE TIP COVER OF THE ROBOTIC SCISSORS CAME LOOSE WHILE BEING REMOVED FROM THE TROCAR AT THE END OF THE PROCEDURE. INITIALLY, THE TIP COVER WAS NOT FOUND, BUT UPON INSERTING A NEW INSTRUMENT, IT WAS DISCOVERED THAT THE COVER WAS STUCK IN THE TROCAR SHEATH AND SUBSEQUENTLY FELL INTO THE ABDOMEN WHEN THE ROBOTIC INSTRUMENT WAS ADVANCED. THE COVER HAD TO BE RETRIEVED FROM THE ABDOMEN AND BROUGHT OUT THROUGH THE TROCAR SHEATH, WHICH TOOK ABOUT TWENTY MINUTES. THE TIP COVER HAD BEEN APPLIED BY AN EXPERIENCED TECHNICIAN WHO ASSERTED THAT IT WAS PROPERLY SECURED WITH NO VISIBLE ORANGE LINE. NO DAMAGE WAS NOTED TO THE CANNULA, TIP COVER, OR INSTRUMENT. THE TIP COVER AND SCISSORS ARE 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 PANCREATODUODENECTOMY PROCEDURE, THE FRONT END OF THE HARMONIC ACE INSTRUMENT BROKE. THE CUSTOMER INDICATED THAT THE FRACTURED PART WAS COMPLETELY REMOVED AND NO FRAGMENT REMAINED IN PATIENT. IT IS UNCLEAR IF A FRAGMENT FROM THE INSTRUMENT ACTUALLY FELL INSIDE THE PATIENT AND WAS SUBSEQUENTLY RETRIEVED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DA VINCI SUREFORM60 STAPLER DID NOT CONNECT THE DA VINCI ARMS. IT WOULD NOT RECOGNIZE STAPLER AND NEW STAPLER WAS USED.

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, A PIECE OF THE ACCESS PORT BROKE OFF 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 FRONT END OF THE HARMONIC ACE INSTRUMENT WAS FRACTURED. AFTER CONFIRMING WITH THE CLINICAL CUSTOMER, THE FRACTURED PART HAD BEEN COMPLETELY REMOVED, AND NO FRAGMENT REMAINED IN 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 SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT COULD NOT BE IDENTIFIED DURING THE OPERATION. THE TIP BROKE, FELL INTO THE PATIENT, AND WAS REMOVED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED AN ADRENALECTOMY SURGICAL PROCEDURE, NOTICED THERE WAS A PIECE OF PLASTIC LOCATED INSIDE THE PATIENT. THERE WERE 10 DIFFERENT INSTRUMENTS USED IN THE PROCEDURE AND THE CUSTOMER WAS UNSURE ABOUT THE ORIGIN OR SOURCE OF THE PLASTIC FOREIGN BODY. THE CUSTOMER STATED THAT THERE WAS A BROKEN PERMANENT CAUTERY HOOK (PCH) INSTRUMENT NOTED DURING THE CASE. NO POST-OPERATIVE TESTS WERE DONE. A SURGICAL TECHNICIAN WAS ABLE TO RETRIEVE THE FRAGMENT 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: 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 SURGERY, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE AS THE NURSE ATTEMPTED TO CLEAN A BLOOD SCAB FROM IT. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. IT WAS CONFIRMED THAT NO FOREIGN OBJECTS WERE LEFT IN THE PATIENT'S BODY. THE INSTRUMENT HAD BEEN INSPECTED PRIOR TO USE AND WAS OPERATED CORRECTLY. THE BROKEN PART AND THE INSTRUMENT WERE RETURNED FOR TESTING. NO RELATED COMPLICATIONS OCCURRED. FEEDBACK INDICATED THAT THERE WAS NO COLLISION BETWEEN THE HARMONIC ACE AND OTHER INSTRUMENTS, AND THE SURGEON WAS KNOWLEDGEABLE ABOUT THE WORKING PRINCIPLE AND PRECAUTIONS ASSOCIATED WITH USING THE 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 review of the article reported that a patient developed ventricular premature contractions followed by ventricular fibrillation approximately 40 minutes after receiving a high-dose mannitol infusion during Da Vinci robotic-assisted partial nephrectomy. Cardiopulmonary resuscitation and 3 rounds of defibrillation were performed along with arterial line placement and large-bore venous access. The patient was admitted to the intensive care unit for further evaluation and management. The diagnosis was variant angina due to significant coronary artery spasm. The patient recovered without neurologic sequelae and appropriate medication was initiated.

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 SURGICAL PROCEDURE, THERE WERE NO ISSUES WITH INSTRUMENT CHECKS BEFORE SURGERY, AND NO COLLISIONS OR IMPACTS WITH INSTRUMENTS DURING SURGERY. WHILE CUTTING TISSUE, THE TIP OF THE HARMONIC ACE DEVICE DISASSEMBLED AND FELL INTO THE PATIENT'S ABDOMINAL CAVITY. THE FRAGMENTS WERE RETRIEVED. 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 WAS NOTED. THE SURGICAL TASK BEING PERFORMED AT THE TIME THE FRAGMENT FELL INSIDE THE PATIENT WAS DISSECTION. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE FRAGMENTS DID NOT FALL INSIDE OF THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE SURGICAL PROCEDURE PRIOR TO THE BREAKAGE. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. IT WAS VISUALLY CONFIRMED THAT NO FRAGMENTS WERE LEFT BEHIND. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS, SUCH AS AN X-RAY OR ULTRASO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: One patient experienced deep venous thrombosis and subsequent pulmonary embolus requiring placement of an inferior vena cava filter.

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 CHOLECYSTECTOMY PROCEDURE, A SMALL PIECE OF A UNIVERSAL SEAL BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED. HOWEVER, IT IS UNCLEAR HOW THE FRAGMENT WAS RETRIEVED AND THE PROCEDURE OUTCOME IS UNKNOWN. THE OR STAFF INDICATED THAT THAT THE UNIVERSAL SEAL HAD LOOKED INTACT. THE FRAGMENT WAS NOT SAVED.

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 WHILE THE SURGEON WAS DISSECTING. A DEVICE FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY WITH A BACKUP HARMONIC ACE INSTRUMENT. THERE WAS A 20 MINUTE PROCEDURE DELAY DUE TO THE REPORTED ISSUE. NO POST-OPERATIVE TESTS, SUCH AS AN X-RAY OR ULTRASOUND, WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. FURTHERMORE, 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS MCS (MCS) TIP COVER ACCESSORY CAME OFF THE INSTRUMENT AND FELL INTO A PATIENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS NOT INSPECTED PRIOR TO USE. THE MCS TIP COVER ACCESSORY WAS NOT RETRIEVED. THE SURGEON WAS MOVING THE MCS WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE PROCEDURE. THE MCS COLLIDED WITH ANOTHER INSTRUMENT DURING THE PROCEDURE. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE PROCEDURE, AND NO ORANGE SURFACE WAS VISIBLE WHEN INSTALLED. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. THE INSTALLATION TOOL WAS USED. NO ELECTROLUBE OR OTHER LUBRICANT WAS APPLIED TO THE MCS PRIOR TO MCS TIP COVER ACCESSORY INSTALLATION. THERE WAS NO DIFFICULTY IN REMOVING THE MCS AND THE MCS TIP COVER ACCESSORY THROUGH THE CANNULA. THE INSTRUMENT WAS REM