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.

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.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MPS REPORTED AN INCIDENT DURING A MAKO KNEE CASE, WHERE THE SURGEONS THOUGHT THAT BOTH FEMUR AND TIBIA CUT WERE INACCURATE. THE INCORRECT CUTTING FOR BOTH FEMUR AND TIBIA HAS RESULTED IN MALPOSITION OF IMPLANT, COMPROMISING THE KNEE STABILITY. THE SESSION FILE WILL BE UPLOADED NEXT WEEK. PLEASE HELP INVESTIGATE THIS CASE AND GET BACK TO US ASAP. CASE TYPE/APPLICATION: (B)(4).

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT "PIF" FROM LEVELS T11-PELVIS ON 7/31. THE PATIENT WAS FOUND TO HAVE PROXIMAL JUNCTIONAL KYPHOSIS (PJK) AND UNDERWENT SURGERY TO REVERSE THIS. THE PATIENT WAS IMPROVING FOLLOWING INDEX THE SURGERY, BUT DEVELOPED MID BACK PAIN ALONG THE PROXIMAL ASPECT OF THE THORACOLUMBAR FUSION, WHICH WAS DIFFERENT FROM THE PATIENT'S PREOPERATIVE PAIN. THE PATIENT DENIED ANY LOWER EXTREMITY PAIN, PARESTHESIA, OR WEAKNESS, SADDLE PARESTHESIA OR BOWEL/BLADDER INCONTINENCE. ON IMAGING, THE PATIENT WAS FOUND TO HAVE A BURST FRACTURE OF T11 VERTEBRAE WITH PJK AT T10-11. THE PATIENT THEN UNDERWENT A MAGNETIC RESONANCE IMAGING (MRI) SCAN, MEDICATION REFILLS, AND SUBSEQUENTLY AN EXTENSION FROM THEIR FUSION FROM T4-T1. THORACIC KYPHOSIS MEASURED AT 76 DEGREES, LUMBAR LORDOSIS MEASURED 59 DEGREES, PELVIC INCIDENCE MEASURED TO THE 70S, AND PELVIC TILT MEASURED AT 35 DEGREES. THE BILATERAL POSTERIOR INSTRUMENTED SCREW AND ROD FIXATION WAS PRESENT FROM T11 TO THE PELVIS. THE METALLIC INTERBODY DEVICES WERE PRESENT AT L4-5, L5-6, L6-S1 WITH ANTERIOR PLATE FIXATION AT L6-S1.

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

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER WE MADE OUR CUTS WITH THE MAKO DR. REALIZED THE POPLITEUS WAS CUT EITHER DURING TIBIAL CUT OR POSTERIOR FEMORAL CUT. CASE TYPE / APPLICATION: TKA 2.0.

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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: OROSZ, L. D., LEE, N. J., GUM, J. L., LEHMAN, R. A., HAGE, T. R., KATZ, J., AMELL-ANGST, T., ROY, R. T., POULTER, G. T., HAINES, C. M., JAZINI, E., GOOD, C. R. (2025). NINETY-DAY COMPLICATION AND REVISION SURGERY RATES USING NAVIGATED ROBOTICS IN THORACOLUMBAR SPINE SURGERY: A PROGRSS INTERIM ANALYSIS. INTERNATIONAL JOURNAL OF SPINE SURGERY, 19(4), 437¿443. HTTPS://DOI.ORG/10.14444/8777 SUMMARY: BACKGROUND: INDIVIDUALLY, ROBOTIC GUIDANCE AND 3-DIMENSIONAL NAVIGATION ASSISTANCE HAVE BEEN SHOWN TO IMPROVE SURGICAL OUTCOMES AND ACCURACY IN SPINE SURGERY. THE PAIRING OF THESE TECHNOLOGIES MAY FURTHER IMPROVE OUTCOMES; HOWEVER, DATA ARE NEEDED TO SUPPORT THIS THEORY. IN THE PROSPECTIVE ROBOTIC-GUIDED REGISTRY OF SPINE SURGERY (PROGRSS), OUTCOMES WERE TRACKED FOR CASES USING A BONE-MOUNTED INTEGRATED ROBOTIC-ASSISTED NAVIGATION SYSTEM. THIS INTERIM ANALYSIS REPORTS ON 90-DAY COMPLICATIONS AND REVISIONS. METHODS: ADULTS UNDERGOING NAVIGATED ROBOTIC THORACOLUMBAR SURGERY FROM 2020 TO 2022 WERE PROSPECTIVELY ENROLLED BY 6 SURGEONS AT 4 DISTINCT CENTERS. MEDICAL, SURGICAL, AND ROBOT-RELATED COMPLICATIONS AND REVISION SURGERIES WERE COLLECTED POSTOPERATIVELY FOR UP TO 90 DAYS AND ANALYZED. RE

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.

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 CART BOOT UP ISSUE AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED 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.

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, VERTEBRAL FUSION, 2 LUMBAR LEVELS. IT WAS REPORTED THAT AFTER FINISHING THE REGISTRATION, THE ARM WAS SENT TO THE PLANNED TRAJECTORIES AND IT WAS NOT ALIGNED WHAT WAS SHOWN IN THE SCREEN IN THE GUIDANCE SYSTEM VERSUS REALITY. THEY REPEATED THE PROCEDURE FROM SNAPSHOT. A NEW SNAPSHOT AND REGISTRATION (AP AND LATERAL) WERE PERFORMED AND THE EQUIPMENT WAS FINE. THEY HAD PROBLEMS FOR THE CAMERA TO MAKE THE SNAPSHOT. THE PATIENT'S NERVE ROOT WAS AFFECTED AND THIS WAS REALIZED AFTER FINISHING THE SURGERY. THE SURGICAL DELAY WAS APPROXIMATELY 1-HOUR. TRAJECTORY WAS MISALIGNED BY GREATER THAN 10 MILLIMETERS (MM). ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SNAPSHOT ISSUE WAS NOT RELATED TO THE INACCURACY/INJURY EVENT. PROBLEMS WERE ENCOUNTERED WHEN TRYING TO FIND THE POSITION OF THE NAVIGATION CAMERA TO SEE THE ROBOTIC REFERENCE FRAME AND THE SNAPSHOT FRAME AT THE SAME TIME, BUT AFTER ACHIEVING, THE NAVIGATION WAS PROPER.

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.

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 THE SURGERY WAS PERFORMED AT THE L3-4 SITE, INSTEAD OF THE L3-5 SITE. THIS WAS NOT DISCOVERED DURING THE SURGERY OR DURING THE PATIENT'S STAY IN THE HOSPITAL. UPON THE PATIENT'S RETURN VISIT, HE WAS ADVISED BY THE SURGEON THAT THE SURGERY WAS PERFORMED AT THE WRONG LEVEL. AN ADDITIONAL SURGERY AT THE CORRECT SITE WAS SCHEDULED FOR ON (B)(6) 2025. THE PATIENT CLAIMS TO HAVE SEVERE PAIN, DIFFICULTY IN AMBULATING AND FOOT DROP.