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, THE HARMONIC ACE INSTRUMENT¿S BLADE BROKE OFF WHILE THE SURGEON WAS MARKING LIVER TISSUE WITH OPENED JAWS. THE INSTRUMENT WAS ONLY IN USE FOR FIVE MINUTES. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 18-JAN-2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT WAS INSPECTED BEFORE THE OPERATION. THE HARMONIC ACE INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT DURING THE OPERATION. THE FRAGMENT WAS RETRIEVED WITH A LAPAROSCOPIC GRASPING FORCEPS. A REPLACEMENT INSTRUMENT WAS USED TO COMPLETE THE SURGERY. THE PATIENT DID NOT SUSTAIN ANY INJURIES AND DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. THE PATIENT¿S CURRENT HEALTH STATUS WAS REPORTED TO BE GOOD. NO POST-OPERATIVE EXAMINATIONS WERE PERFORMED TO LOCATE ANY REMAINING FRAGMENTS. NO PHOTO OR VIDEO WAS SENT TO ISI FOR REVIEW. THE PATIENT DEMOGRAPHICS, RELEVANT TESTS, AND RELEVANT HISTORY WERE NOT 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 SLEEVE GASTRECTOMY SURGICAL PROCEDURE, A PIECE OF THE SYNCHROSEAL INSTRUMENT WAS SPOTTED RESTING ON THE PATIENT'S STOMACH ALONG THE STAPLE LINE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE BY A GRASPER INSTRUMENT. IT IS UNKNOWN WHEN THE INSTRUMENT BROKE. THEY FOUND THE FRAGMENT NEAR THE STAPLE LINE NEAR THE END OF THE PROCEDURE. THE SYNCHROSEAL DID NOT COLLIDE WITH ANOTHER INSTRUMENT OR HARD OBJECT WHILE INSIDE THE PATIENT. NO POST OPERATIVE TESTS WERE PERFORMED. THERE WAS NO REPORTED POST-OPERATIVE COMPLICATIONS. THE SURGEON DOES NOT KNOW WHAT CAUSED THE ISSUE. THE INSTRUMENT AND FRAGMENT WILL BE RETURNED BACK TO ISI FOR EVALUATION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT FOLLOWING A TKA DONE BY ROSA KNEE SURGICAL INSTRUMENTATION, FEMORAL NOTCHING WAS NOTICED IN THE POST OPERATIVE X-RAYS. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT HAS BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN 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 SIGMOIDECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS BROKEN AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON JANUARY 20, 2022 INTUITIVE SURGICAL (IS) CONTACTED THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE FIRST ASSISTANT REMOVED THE FRAGMENT WITH A LAPAROSCOPIC INSTRUMENT. THE SURGICAL STAFF DOUBLE CHECKED THE PATIENT'S ANATOMY THEY WERE WORKING ON TO CONFIRM THAT NO FRAGMENT REMAINED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. IT WAS NOT NECESSARY TO PERFORM POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRA SOUND TO CHECK FOR REMAINING FRAGMENTS. AS PER THE SURGEON, THE CAUSE OF THE INSTRUMENT BREAKAGE IS UNKNOWN. THE INSTRUMENT WAS IN USE DURING THE WHOLE THE PROCEDURE. THE INSTRUMENT WAS INSPECTED BY THE NURSE BEFORE THEY HANDED IT TO THE SURGEON. NO DAMAGE WAS NOTICED. NO ISSUE OF THE INSTRUMENT FUNCTIONALITY NOTICED DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF INDICATED THAT THE INSTRUMENT DID NOT COLLIDE WITH ANOTHER ONE DURING PROCEDURE. THE INSTRUMENT WAS REMOVED WITH N

ROSA Robotic Surgery — 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 TKA SURGERY WITH ROSA INSTRUMENTATION, THE DISTAL FEMUR CUT WAS VALIDATED 3MM OVER THE PLANNED RESECTION. THE CUT WAS VALIDATED USING ROSA AND STANDARD CALIPERS. DUE TO THIS OVER-RESECTION OF THE DISTAL FEMUR, THE SURGEON DOWNSIZED BY 2 SIZES TO BALANCE THE SPACE. NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS 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 AFTER A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE BLEEDING. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: ON POST-OPERATIVE DAY #1, THE PATIENT BECAME HYPOTENSIVE AND FELL. AS A RESULT, THE PATIENT ALLEGEDLY BROKE HER VERTEBRAE. THE PATIENT WAS TAKEN BY AMBULANCE TO A NEARBY HOSPITAL (DIFFERENT FROM THE HOSPITAL WHERE THE DA VINCI-ASSISTED SLEEVE GASTRECTOMY WAS PERFORMED). THE PATIENT WAS ADMITTED IN THE ICU. A CT SCAN REVEALED A HEMATOMA. AN ARTERIOGRAM CONFIRMED THERE WAS NO ACTIVE BLEEDING. THE PATIENT UNDERWENT A SECOND PROCEDURE FOR THE BROKEN VERTEBRAE. THE SURGEON REPORTED THAT HE BELIEVES THE POSTOPERATIVE BLEEDING WAS FROM THE RIGHT GASTROEPIPLOIC OR THE SHORT GASTRIC VESSEL AND WAS RELATED TO AN ALLEGED INSUFFICIENT SEAL INVOLVING THE USE OF A SYNCHROSEAL INSTRUMENT. THE SURGEON DOES NOT SKELETONIZE THE VESSELS BEFORE SEALING.

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-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS LEFT UPPER LOBE (LUL) (TARGET IN THE LINGULA), AND THE PNEUMOTHORAX WAS DISCOVERED ON THE RIGHT SIDE WHEN THE PHYSICIAN RECEIVED A RADIAL IMAGE AND DIGITAL RADIOGRAPHY (DX). A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE FOLLOWING DAY THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS RELEASED FROM THE HOSPITAL.

ROSA Robotic Surgery — 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 ROSA PLATFORM DURING A TKA SURGERY, THERE WAS AN OVER RESECTION OF TIBIA BY 3MM. A THICKER THAN EXPECTED POLY IMPLANT HAD TO BE USED. NO ADDITIONAL CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.