ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING EXCELSIUS GPS WERE GUIDED IN INACCURATE TRAJECTORIES IN A T10-PELVIS.

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

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THERE WAS A RADIAL ERROR >1.5MM AT ENTRY FOR I' J'AND K'. DEFLECTION VERBALIZED BY CSR DURING DRILLING. J' DRILL BIT WAS RE-DRILL AND REPOSITIONED ONE TIME.

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 THAT A NON-RECOVERABLE FAULT OCCURRED. THE CUSTOMER POWER-CYCLED THE SYSTEM MULTIPLE TIMES; HOWEVER, THE ERROR RETURNED. THE CUSTOMER UNDOCKED AND POWER CYCLED THE SYSTEM AGAIN. THE ERROR RETURNED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CALLER TO HARD POWER CYCLE THE SYSTEM AND PERFORM AN EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC). THE SYSTEM POWERED UP AND AN ERROR AGAINST PATIENT SIDE MANIPULATOR (PSM) #2 WAS PRESENT. THE TSE HAD THE CALLER PERFORM A HARD POWER CYCLE AND PERFORM AN EPO AGAIN, KEEPING THE SYSTEM OFF LONGER. THE ERROR(S) RETURNED. THE TSE ADVISED TO CONTINUE TO PERFORM HARD CYCLES TO SEE IF THE ERROR WOULD CLEAR, AND ALSO ADVISED THAT THE ERRORS COULD RETURN. THE PROCEDURE WAS ULTIMATELY ABORTED AFTER ANESTHESIA HAD 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: Intraoperative complications consisted of five vaginal injuries and one small bowel serosa injury requiring simple suturing. Vaginal injuries occurred in three patients in the FR group and two in the SR group (P = 0.7) and were closed in two layers; the mesh was trimmed to avoid the repaired site. The FR group had one grade 3 complication, a small bowel obstruction caused by an adhesion and released by laparotomy.The author responded and reported that there were no complications mentioned in the article that were caused/contributed by an Intuitive product and no da Vinci device malfunctions.

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 IN THE MATERNITY OPERATING ROOM, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED AND ENDED UP IN THE PATIENT'S INTRAPERITONEAL CAVITY, WHICH THE SURGEON SUBSEQUENTLY REMOVED. THE MCS AND SHEATH WERE REPLACED, BUT THE SECOND MCS TIP COVER ACCESSORY ALSO SLIPPED FROM THE SECOND PAIR, AND IT WAS OBSERVED BY SEVERAL PEOPLE IN THE OPERATING ROOM. UPON VERIFICATION, IT WAS FOUND THAT BOTH SHEATHS HAD THE SAME LOT NUMBER. THE MCS INSTRUMENT DID NOT EXPERIENCE ANY ISSUES DURING USE. THE INCIDENT RESULTED IN PROLONGED SURGERY AND INCREASED STRESS FOR THE SURGEON. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND TIP COVER WERE INSPECTED BEFORE USE, AND THERE WAS NOTHING UNUSUAL NOTED. THE TIP COVER FELL DURING DISSECTION. IT WAS RETRIEVED USING GRASPING FORCEPS AND IT WAS REMOVED THROUGH THE CANNULA WITHOUT DIFFICULTY. THERE WAS NO COLLISION. THE MCS INSTRUMENT DID NOT EXPERIENCE ANY FUNCTIONALITY ISSUES. THE TIP COVER APPEARED TO BE PROPERLY INSTALLED; A FOUR EYES CHECK HAD BEEN PERFORMED TO VERIFY PROPER INSTALLATION. THE ORANGE SURFACE WAS NOT VISIBLE, AND THE TIP

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 CAME OFF THE MCS INSTRUMENT INTRAOPERATIVELY. DURING THE EXCHANGE BETWEEN 2 INSTRUMENTS ON ARM #3, THE CUSTOMER NOTICED THAT THE MCS TIP COVER ACCESSORY WAS MISSING FROM THE MCS INSTRUMENT. THE CUSTOMER FOUND THE MCS TIP COVER ACCESSORY STUCK IN THE PERITONEAL WALL. LONGER ANESTHESIA TIME AND WIDENING OF THE INCISION WERE REQUIRED TO FIND/REMOVE THE MCS TIP COVER ACCESSORY.

Crash With

Other, see Narrative

SV Pre-Crash Movement

Proceeding Straight

SV Contact Area

Front Right

SV Precrash Speed (MPH)

4

CP Pre-Crash Movement

Other, see Narrative

CP Contact Area

Unknown

Within ODD?

Yes

Automation System Engaged?

ADS

Roadway Type

Street

Weather

Clear

Make

JAGUAR

Model

I-PACE

SV is the subject vehicle — the one whose operator filed the report. CP is the crash partner, the other party. Contact area is where each was struck. NHTSA requires a report for any crash involving the driving system regardless of fault.

On July [XXX], 2025 at 6:20 PM MT a Waymo Autonomous Vehicle ("Waymo AV") operating in Mesa, Arizona was in a collision involving a detached object from a pickup truck on [XXX] at [XXX]. The Waymo AV was traveling northbound in the left turn lane on [XXX] and slowing for a queue of traffic at the intersection with [XXX]. A pickup truck was traveling southbound in the leftmost lane on the west side of [XXX] without its rear driver side tire. As the SUV continued to proceed straight, an object detached from the pickup truck's rear axle and rolled into the Waymo AV's lane of travel, making contact with the front of the Waymo AV. At the time of the impact, the Waymo AV's Level 4 ADS was engaged in autonomous mode. The Waymo AV sustained damage. The passenger in the Waymo AV later alleged an injury of unspecified nature and severity. Waymo is reporting this crash under Request No. 2 of Standing General Order 2021-01. Waymo may supplement or correct its reporting with additional information as it may become available.

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 Robot-assisted Partial Nephrectomy (RAPN) surgery, the patient experienced an accidental massive hemorrhage and hypotension due to sudden iatrogenic rupture of the IVC. The procedure was converted to open nephrectomy. The patient was transferred to the Intensive Care Unit on Synchronized Intermittent Mandatory Ventilation (SIMV) ventilator mode.The patient remained hemodynamically stable and was extubated and subsequently discharged from the hospital on postoperative day 7.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.

Crash With

Animal

SV Pre-Crash Movement

Proceeding Straight

SV Contact Area

Front Right, Bottom

SV Precrash Speed (MPH)

13

CP Pre-Crash Movement

Other, see Narrative

Within ODD?

Yes

Automation System Engaged?

ADS

Roadway Type

Street

Weather

Clear

Investigating Agency

None

Make

TOYOTA

Model

Highlander

SV is the subject vehicle — the one whose operator filed the report. CP is the crash partner, the other party. Contact area is where each was struck. NHTSA requires a report for any crash involving the driving system regardless of fault.

A Zoox vehicle (Vehicle 1) in autonomous mode was traveling in the left lane on southwest-bound [XXX] toward [XXX] in San Francisco when a ball, immediately followed by a dog, entered the roadway from between parked cars on the left side of [XXX] directly into the path of the Zoox vehicle. The Zoox vehicle braked in response, but its underbody made contact with the dog. The Zoox vehicle operator then disengaged autonomous mode and brought the vehicle to a stop. The Zoox vehicle operator then reversed the vehicle to free the dog. The dog owner did not indicate injuries to the dog at the scene. The dog and its owner then returned to the sidewalk and the Zoox vehicle operator drove the vehicle from the scene. The police were not called. Zoox subsequently received an email alleging injuries to the dog, "abrasions behind its left front leg and a possible cracked rib."

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 IN THE MATERNITY OPERATING ROOM, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED AND ENDED UP IN THE PATIENT'S INTRAPERITONEAL CAVITY, WHICH THE SURGEON SUBSEQUENTLY REMOVED. THE MCS AND SHEATH WERE REPLACED, BUT THE SECOND MCS TIP COVER ACCESSORY ALSO SLIPPED FROM THE SECOND PAIR, AND IT WAS OBSERVED BY SEVERAL PEOPLE IN THE OPERATING ROOM. UPON VERIFICATION, IT WAS FOUND THAT BOTH SHEATHS HAD THE SAME LOT NUMBER. THE MCS INSTRUMENT DID NOT EXPERIENCE ANY ISSUES DURING USE. THE INCIDENT RESULTED IN PROLONGED SURGERY AND INCREASED STRESS FOR THE SURGEON. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND TIP COVER WERE INSPECTED BEFORE USE, AND THERE WAS NOTHING UNUSUAL NOTED. THE TIP COVER FELL DURING DISSECTION. IT WAS RETRIEVED USING GRASPING FORCEPS AND IT WAS REMOVED THROUGH THE CANNULA WITHOUT DIFFICULTY. THERE WAS NO COLLISION. THE MCS INSTRUMENT DID NOT EXPERIENCE ANY FUNCTIONALITY ISSUES. THE TIP COVER APPEARED TO BE PROPERLY INSTALLED; A FOUR EYES CHECK HAD BEEN PERFORMED TO VERIFY PROPER INSTALLATION. THE ORANGE SURFACE WAS NOT VISIBLE, AND THE TIP

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 DEVELOPED A TRACHEAL MICRO-PERFORATION AT BERRY¿S LIGAMENT A WEEK AFTER SURGERY, WHICH WAS SUCCESSFULLY MANAGED WITH COMPRESSION DRESSING AND CONSERVATIVE TREATMENT, ACHIEVING TRACHEAL HEALING WITHOUT INFECTION.

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 PRIOR TO THE START - POST ANESTHESIA DA VINCI-ASSISTED RENAL TUMORECTOMY PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) WOULD NOT POWER ON, DESPITE BEING POWERED DURING SYSTEM INSTALLATION. THE PORTS WERE IN PLACE WHEN THE PROBLEM WAS DISCOVERED. VARIOUS TROUBLESHOOTING STEPS WERE TAKEN, INCLUDING CHANGING THE POWER CORD LOCATION MULTIPLE TIMES, TOGGLING THE SSC SWITCH BREAKER, SWAPPING THE POWER CORD LOCATION WITH A KNOWN WORKING ONE, WIGGLING THE POWER CORD, AND ENSURING THE POWER CORD WAS PROPERLY SEATED IN THE CONSOLE. THE CUSTOMER HAD ONLY ONE SSC, AND IT WAS DETERMINED THAT A REPLACEMENT OF THE CONSOLE POWER CORD WAS NOT POSSIBLE BY THE BIOMED OR ELECTRICAL DEPARTMENT. SUBSEQUENTLY, A SALES REPRESENTATIVE CALLED TO REQUEST AN UPDATE, AND IT WAS CONFIRMED THAT ON SITE TROUBLESHOOTING WITH SPARE PART REPLACEMENT WAS NECESSARY TO RESOLVE THE ISSUE. THE PROCEDURE WAS ABORTED POST-ANESTHESIA AND PORT PLACEMENT, AND IT WAS UNKNOWN IF OR WHEN THE PROCEDURE WOULD BE RESCHEDULED.

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, A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER FELL OFF WHILE INSTALLED ON AN MCS INSTRUMENT. THE CUSTOMER WAS ABLE TO SAFELY REMOVE THE MCS TIP COVER ACCESSORY FROM THE PATIENT AND PLACED A NEW ONE ON THE MCS INSTRUMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON WAS DOING A HYSTERECTOMY. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED AS USUAL. NO DAMAGE WAS NOTED. THE MCS TIP COVER ACCESSORY WAS INSTALLED CORRECTLY WITH NO LUBRICANT USED. THE UTERUS WAS VERY LARGE AND DIFFICULT TO MOVE AROUND. THE PROCEDURE WAS 2.5 HOURS LONGS AND THE MCS INSTRUMENT WAS USED THE ENTIRE CASE. THE ENTIRE MCS TIP COVER ACCESSORY WAS REMOVED WITHOUT DIFFICULTY. NO FRAGMENT WAS NOTED TO BE LEFT IN THE PATIENT. THERE WAS NO ISSUE WITH THE USE OF THE SCISSORS. THE MCS INSTRUMENT AND A TENACULUM FORCEPS INSTRUMENT WERE ON THE SAME SIDE OF THE PATIENT. THE MCS TIP COVER ACCESSORY WAS DISPOSED OF AND THE MCS INSTRUMENT IS STILL IN USE. NO PHOTOS WERE TAKEN.

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 PORTION OF THE BLACK RUBBER ON THE TROCAR CAPS BREAKING OFF AND FALLING INSIDE OF THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.

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; WHILE USING THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, THE PATIENT SUSTAINED A BLADDER BURN. PRIOR TO ACTIVATION, THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED. THE GROUNDING PAD WAS CONFIRMED TO BE CORRECTLY PLACED AND FREE OF DEFECTS. THE ERBE GENERATOR WAS IN USE AT THE TIME, WITH THE COAGULATION MODE SET TO SWIFT: 4. THE INJURY OCCURRED WHILE THE MCS INSTRUMENT WAS ACTIVELY DELIVERING ENERGY FOR DISSECTION OF THE BLADDER NECK. AT THE TIME OF ACTIVATION, THE INSTRUMENT¿S JAWS WERE NEITHER IMMERSED IN FLUID NOR CONTAMINATED WITH CARBONIZED TISSUE OR OTHER BIOLOGICAL DEBRIS. THE MCS TIP COVER ACCESSORY WAS OBSERVED TO HAVE COME INTO CONTACT WITH BLADDER TISSUE, RESULTING IN A THERMAL INJURY. THE BURN WAS ADDRESSED WHILE PERFORMING THE VESICOURETHRAL ANASTOMOSIS. NO ADDITIONAL TISSUE RESECTION WAS REQUIRED, AND THERE WAS NO BLEEDING AS A RESULT OF THE INJURY. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER WAS CONSULTED AND SUGGESTED THE POSSIBILITY OF A SHORT CIRCUIT DUE TO COMPROMISED INSULATION. THIS MAY HAVE CAUSED ENERGY TO BE REDIRECTED TO THE INSTRUMENT¿S SHAFT OR MCS T

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 NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE, THE PATIENT SUFFERED A BURN. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE THERMAL DAMAGE TO OCCUR OR THE EXTENT OF THE INJURY. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE. THE BROKEN PART WAS REMOVED AND IT WAS NOTED THAT NO FRAGMENTS REMAINED IN THE PATIENT. HOWEVER, IT IS UNCLEAR IF ANY FRAGMENTS ACTUALLY 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: A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE. INTRA-OPERATIVELY, A SKIN BURN/THERMAL INJURY WAS OBSERVED ON THE LEFT BREAST BY THE CASE SUPPORT ENGINEER. THERE WAS NO REPORTED CAUSE OF THE BURN. THE PHYSICIAN REPORTED THE SEVERITY AS MILD, POSSIBLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE RECONSTRUCTION PROCEDURE AND NOT RELATED TO THE PATIENT'S PRE-EXISTING CONDITION. THE TREATMENT WAS REPORTED AS XEROFORM DAILY TO THE BURNS AND THE EVENT OUTCOME IS DOCUMENTED AS ONGOING. THE PATIENT WAS DISCHARGED THE DAY AFTER SURGERY. THERE WERE NO DEVICE MALFUNCTIONS ASSOCIATED WITH THE 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 DISTAL PANCREATECTOMY PROCEDURE, THE KNIFE HEAD ON A HARMONIC ACE INSTRUMENT SUDDENLY BROKE. IT WAS REPORTED THAT NO RESIDUE WAS LEFT IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. IT IS UNCLEAR IF A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: RECTAL TOXICITY DUE TO PROSTATE TREATMENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: RECTAL TOXICITY DUE TO PROSTATE TREATMENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY PROCEDURE, ONE SIDE OF THE HARMONIC ACE INSTRUMENT JAW BROKE WHILE THE SURGEON WAS DISSECTING AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED DURING THE SAME PROCEDURE AND WAS VISUALLY CONFIRMED TO HAVE BEEN FULLY RECOVERED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED FOR REMOVAL OF THE FRAGMENT AND NO POST-OPERATIVE TESTS WERE CONDUCTED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACKUP HARMONIC ACE INSTRUMENT. 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: A review of an article was performed that presented a retrospective review of experiences with robotic lymphadenectomy procedures. The article noted one man was diagnosed with inguinal panniculitis (on the side of radical inguinal lymph node dissection (rILND)), which was managed successfully with a 14-day course of cefditoren.The corresponding author was contacted and stated that the reported postoperative lymphoceles were not caused by, nor attributed to, any Intuitive Surgical device. They represent well-recognized complications following inguinal lymph node dissection. No da Vinci system or instrument malfunctions occurred during any of the procedures reported in the manuscript. Consequently, no corrective actions or interventions related to device malfunction were required. The patients were adult males undergoing robotic inguinal lymphadenectomy for penile cancer. No additional patient-specific information can be provided due to privacy regulations.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TIP WAS BENT, AND A PIECE OF THE BLACK PART FELL INSIDE THE PATIENT, BUT THE DOCTOR RETRIEVED IT. 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: A REVIEW OF AN ARTICLE THAT EVALUATED THE PERIOPERATIVE, ONCOLOGIC, AND FUNCTIONAL OUTCOMES OF SALVAGE TRANSORAL ROBOTIC SURGERY (TORS) WITH SUBMENTAL ISLAND FLAP RECONSTRUCTION FOR RECURRENT OROPHARYNGEAL SQUAMOUS CELL CARCINOMA (OPSCC) WAS PERFORMED. THE RETROSPECTIVE STUDY ANALYZED 8 PATIENTS UNDERGOING SALVAGE TORS WITH SUBMENTAL ISLAND FLAP RECONSTRUCTION BETWEEN DECEMBER 2019 AND FEBRUARY 2024. TWO PATIENTS EXPERIENCED POSTOPERATIVE COMPLICATIONS, INCLUDING NECK HEMATOMA REQUIRING INTERVENTION AND DEHYDRATION/FAILURE TO THRIVE REQUIRING READMISSION. TWO DEATHS WERE OBSERVED DURING LONG-TERM FOLLOW-UP (AT 4 MONTHS AND 27 MONTHS POSTOPERATIVELY), ACKNOWLEDGED BY THE AUTHORS AS PART OF OVERALL SURVIVAL OUTCOMES. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT ATTRIBUTE ANY ADVERSE EVENTS TO AN INTUITIVE SURGICAL, INC. (ISI) DEVICE. FOLLOW-UP WITH THE AUTHOR PROVIDED THE FOLLOWING INFORMATION: "THOSE WERE ANTICIPATED ONCOLOGIC OUTCOMES, INDEPENDENT OF THE ROBOT. THERE WERE NO MALFUNCTIONS."

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 review of an article was performed that presented a retrospective review of experiences with robotic lymphadenectomy procedures. The article noted four patients developed clinically evident lymphoceles, with one case requiring temporary percutaneous drainage under local anesthesia due to the risk of cutaneous ulceration.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: The reported postoperative lymphoceles were not caused by, nor attributed to, any Intuitive Surgical device. They represent well-recognized complications following inguinal lymph node dissection. No da Vinci system or instrument malfunctions occurred during any of the procedures reported in the manuscript. Consequently, no corrective actions or interventions related to device malfunction were required. The patients were adult males undergoing robotic inguinal lymphadenectomy for penile cancer. No additional patient-specific information can be provided due to privacy regulations.

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.