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 H10/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 H10/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 INSTRUMENT SUDDENLY DID NOT WORK. A FRAGMENT FROM AN UNSPECIFIED LOCATION OF THE INSTRUMENT ALLEGEDLY FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO FRAGMENT LEFT.

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 DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX, HEMOPTYSIS, AND DYSPNEA. A PIGTAIL (CHEST TUBE) WAS PLACED AND THE PATIENT WAS HOSPITALIZED AND LATER RELEASED. NO MALFUNCTION, FAULT OR ERRORS WERE REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER PORT PLACEMENT BUT PRIOR TO DOCKING FOR A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SITE WAS HAVING ISSUES WITH ENDOSCOPE ENGAGEMENT. PRIOR TO CALLING IN, INTUITIVE REP HAD THE STAFF RE-DRAPE TWICE AND TRY TWO DIFFERENT ENDOSCOPES. TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE REP THROUGH A HARD POWER CYCLE OF THE PATIENT SIDE CART (PSC) AND REINSTALLATION OF CAMERA ARM STERILE ADAPTER. TSE RECOMMENDED CUSTOMER ATTEMPT A THIRD ENDOSCOPE, BUT SYSTEM WOULD NOT ACCEPT THE THIRD ENDOSCOPE. THE PROCEDURE WAS ABORTED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CONFIRMED THAT PORTS WERE PLACED. THEY WERE PREPARING TO DOCK AND ENTER DIRECTLY INTO THE BLADDER. THEY CUT FACIA AND ENTERED DIRECTLY INTO THE BLADDER. THE REST OF THE INSTRUMENTS WERE DOCKED, BUT THE NONE OF THE ENDOSCOPES WOULD ENGAGE. CONFIRMED THERE WERE NO POST-OP COMPLICATIONS.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE PATIENT WAS ADMITTED FOR IN-PATIENT HOSPITALIZATION. SUPPLEMENTAL OXYGEN WAS ADMINISTERED. THE PATIENT WAS RELEASED TWO (2) DAYS LATER. THE HOSPITAL CLINICAL RESEARCH COORDINATOR REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELAE. AFTER THE PROCEDURE, THE PATIENT REPORTED HAEMOPTYSIS. THE PATIENT¿S HAEMOPTYSIS WAS REPORTED AS POSSIBLY RELATED TO USE OF THE MONARCH SYSTEM. THE PATIENT¿S SYMPTOM WAS REPORTED AS HAVING A CAUSAL RELATIONSHIP TO THE BRONCHOSCOPY PROCEDURE. THE HAEMOPTYSIS WAS REPORTED AS RESOLVED WITHOUT SEQUALAE. IN ADDITION, THE PATIENT REPORTED SHORTNESS OF BREATH. THE PATIENT¿S SHORTNESS OF BREATH WAS REPORTED AS NOT RELATED TO USE OF THE MONARCH SYSTEM. HOWEVER, THE PATIENT¿S SYMPTOM WAS REPORTED AS POSSIBLY RELATED TO THE BRONCHOSCOPY PROCEDURE. ON FEBRUARY 17, 2023, THE PATIENT¿S SHORTNESS OF BREATH WAS REPORTED AS RESOLVED WITHOUT SEQUALAE. THERE WAS NO REPORTED MALFUNCTION OF THE MONARCH BRONCHOSCOPY SYSTEM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT HAD A PIECE OF METAL THAT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD 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 RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE THAT THE BIPOLAR ENERGY WAS NOT WORKING. THE STAFF TRIED TWO DIFFERENT BIPOLAR INSTRUMENT CORDS BEFORE CALLING. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE STAFF TO CYCLE THE ERBE GENERATOR POWER. THE SURGEON CONVERTED TO AN OPEN PROCEDURE. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. (B)(6) FIRST DBS PROCEDURE WITH EGPS AND E3D HAD TO BE ABORTED DUE TO MISSED TRAJECTORIES, THAT IS BELIEVED TO BE DUE TO MERGE ISSUES WITH THE PRE-OP T1 MRI. THE PATIENT WAS ATTACHED TO THE PSS WITH A LEKSELL HEAD-FRAME, AND A THE LEKSELL FRA WAS USED FOR REFERENCE. A NON-STERILE INTRAOP REGISTRATION WAS PERFORMED WITH E3D AND LANDMARKS WERE CHECKED SHOWING AN ACCURATE REGISTRATION. THE PATIENT WAS PREPPED AND DRAPED AND INCISION AND BURR-HOLES WERE MADE. THE ROBOT WAS BROUGHT BACK INTO POSITION AND A THIRD LANDMARK VERIFICATION WAS PERFORMED, A TEST TRAJECTORY WAS SET UP AND THE ROBOT SHOWED ACCURATE PLACEMENT. THE ROBOT WAS SENT TO THE LEFT GPI TRAJECTORY AND THE LEAD WAS PLACED. A STERILE EVALUATION SPIN WAS COMPLETED WITH E3D AND SHOWED AN ANTERIOR TO POSTERIOR LEAD PLACEMENT, BISECTING THE INTENDED TRAJECTORY. LANDMARK CHECKS WERE PERFORMED AGAIN SHOWING A SLIGHTLY DEEP INSTRUMENT IN THE CT SCAN. IT WAS ALSO NOTICED THAT THE ALPHA OMEGA XY BASE STAGE WAS LOOSE AND ROCKING BACK AND FORTH. IT WAS DECIDED TO RE-REGISTER THE PATIENT WHICH WAS SUCCESSFULLY PERFORMED. LANDMARK CHECKS SHOWED AN ACCURATE REGISTRATION. THE ROBOT WAS SENT BACK TO THE TRAJECTORY AND THE LEAD WAS REPL

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE PATIENT'S VAS DEFERENS WAS INJURED. THE ISSUE OCCURRED DURING THE END OF THE PROCEDURE WHILE PERFORMING THE ANASTOMOSIS. THE SURGEON ROTATED THE 0 DEGREE ENDOSCOPE PLUS SEVERAL TIMES WHILE LOOKING FOR A SUTURE NEEDLE, AFTER WHICH THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ALLEGEDLY WENT OUT OF CONTROL TOWARDS THE VAS DEFERENS AND UNINTENTIONALLY TRANSECTED IT. IT IS UNCLEAR IF THE VAS DEFERENS WAS REPAIRED. THE ARTERY AND VEIN NEXT TO THE VAS DEFERENS DID NOT CONTACT THE MCS AND WERE THEREFORE NOT INJURED. WHILE ROTATING THE ENDOSCOPE, AN UNSPECIFIED ¿BAD SOUND¿ WAS HEARD. NO ERROR MESSAGE DISPLAYED. ALL THE INSTRUMENTS WERE THEN REMOVED FROM THEIR RESPECTIVE UNIVERSAL SURGICAL MANIPULATORS (USM)S AND REINSTALLED. THE SURGICAL STAFF THEN CONTINUED THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN 8MM 30 DEGREE ENDOSCOPE. THE SURGEON BELIEVES THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION WAS DUE TO A PROBLEM WITH THE 0 DEGREE ENDOSCOPE PLUS FOLLOWED BY FEELING UNEXPECTED MOVEMENTS WITH THE USMS. THE PATIENT DID NOT EXPERIENCE POST-OPERATIVE COMPLICATIONS AND WAS REPORTED TO BE ¿OKAY¿. THE INTU

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 AS PART OF A CLINICAL TRIAL THAT 2 DAYS AFTER A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME), THE PATIENT EXPERIENCED LIGHTHEADEDNESS WITH NAUSEA AND VOMITING. A NASOGASTRIC WAS PLACED, AND ILEUS WAS SHOWN ON X-RAY. BLOOD WORK SHOWED NO CONCERNS OF BLEEDING OR INFECTION. IV FLUIDS WERE GIVEN TO THE PATIENT. NO MALFUNCTIONS OF SP SYSTEM OR INSTRUMENTS WERE REPORTED, AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS DURING THE SURGERY. ON POST-OPERATIVE DAY (POD) #5, THE PATIENT WAS REPORTED RESOLVED FROM ILEUS. THE PATIENT WAS DISCHARGED ON POD #6 WITH NORMAL BOWEL FUNCTION AND WAS TOLERATING A GENERAL DIET.

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 TONSILLECTOMY SURGICAL PROCEDURE, WHEN ATTEMPTING TO DOCK THEY WERE GETTING A CANNULA INVALID MESSAGE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE CUSTOMER THROUGH EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC) AND ERROR 1162 PERSISTED. THE TSE REVIEWED ONSITE LOGS AND CONFIRMED ERROR CODE 1162. TSE THEN WALKED THE CALLER THROUGH ADDITIONAL EPO OF PSC AND POWERING SYSTEM BACK ON WITH CANNULA INSTALLED AND SYSTEM POWERED ON AND ERROR DID NOT PERSIST. THE CALLER REPORTED THAT THE SURGEON HAD PERFORMED THE SURGERY ¿MANUALLY¿ AND THE CASE WAS COMPLETED WITHOUT THE DAVINCI ROBOT. THERE WAS NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON¿S NAME WAS PROVIDED. THE SURGEON WAS REQUIRED TO CHANGE THE SURGICAL APPROACH TO OPEN SURGERY. THERE WAS NO INJURY 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 NISSEN FUNDOPLICATION-ISOLATED SURGICAL PROCEDURE, A SMALL ROUND FRAGMENT ATTACHED TO THE WRIST OF THE SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE FOUND. THE SURGEON DID NOT KNOW WHEN THE FRAGMENT FELL EXACTLY. THE SURGEON FOUND THE SMALL ROUND FRAGMENT ON THE TISSUE, AND THEN REALIZED IT WAS FROM THE SYNCHROSEAL INSTRUMENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE AND THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE PROCEDURE. THE SURGEON TRIED TO RETRIEVE THE FRAGMENT THROUGH THE CANNULA BUT WAS UNABLE TO DO SO. THE CUSTOMER TRIED TO FIND THE FRAGMENT INSIDE THE PATIENT AGAIN BUT COULD NOT FIND IT. NO FRAGMENTS WERE RETRIEVED. NO POST-OPERATIVE TESTS WERE PERFORMED AS THE FRAGMENT WAS TOO SMALL TO BE REVEALED BY X-RAY. THE PATIENT HAS NOT EXPERIENCED ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

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 HIATAL HERNIA SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT SCREW AT THE DISTAL MECHANISM CAME LOOSE AND FELL INSIDE THE PATIENT. THE SCREW WAS RETRIEVED DURING THE SAME PROCEDURE FROM THE PATIENT WITHOUT INJURY. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROGRASP FORCEPS INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE FOUND. THE INSTRUMENT WAS BEING INSERTED WHEN THE SCREW FELL OUT. THE PROCEDURE HAD JUST STARTED WHEN THE REPORTED ISSUE OCCURRED. THE SURGEON DID NOT NOTICE ANY FUNCTIONALITY ISSUES BEFORE THE INSTRUMENT BROKE. THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS. A NEW INSTRUMENT WAS OPENED AFTER THE SCREW WAS REMOVED AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING POST-SURGICAL COMPLICATIONS RELATED TO 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: REFER TO H10/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 H10/H11 FOR FOLLOW-UP INFORMATION.

The robot "reversed and ran into her" after she had crossed behind it, causing her to fall.