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 UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, DISSECTION OF THE VAGINAL STUMP WAS PERFORMED, AND TISSUE WAS DAMAGED. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE STUMP OF THE VAGINA WAS INJURED DURING THE PROCEDURE. THE CAUSE OF THE INJURY WAS ATTRIBUTED TO THE SURGEON¿S MISJUDGMENT. THE SURGEON CONFIRMED THAT ANOTHER STITCH SHOULD HAVE BEEN PLACED. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS REQUIRED TO REPAIR THE VAGINAL STUMP. ADDITIONALLY, THE SURGEON STATED THAT THE EVENT DID NOT OCCUR AS A RESULT OF THE DA VINCI SURGICAL SYSTEM MALFUNCTION. THE SURGERY WAS COMPLETED AS PLANNED AND THE PATIENT HAS PROGRESSED WELL WITHOUT ANY PROBLEMS.

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 VIA A GENERAL PHYSICIAN INQUIRY THAT AFTER A COMPLETED DA VINCI-ASSISTED GYNECOLOGY PROCEDURE, POSSIBLY ON (B)(6) 2019, PATIENT INJURY WAS REPORTED. THE PATIENT RETURNED TO THE HOSPITAL SIX TO SEVEN DAYS POST DA VINCI PROCEDURE, POSSIBLY ON (B)(6)2019, FOR WHAT WAS DESCRIBED AS ¿REPAIR¿ AS THERE WAS AN OBSERVED ¿TROCAR INJURY¿ AND ¿BOWEL NECROSIS¿. FURTHER DETAIL WAS UNKNOWN. THE PATIENT¿S CURRENT STATUS IS ALSO UNKNOWN.

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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A "PARTIAL NEPHROTIC ROBOTIC LAPAROSCOPIC PROCEDURE" ON (B)(6)2019 WHO WAS READMITTED TO THE HOSPITAL "FOUR DAYS AFTER HER SURGERY" ON (B)(6) 2021 EXHIBITING POST-OPERATIVE SYMPTOMS OF ¿REGURGITATED APPROXIMATE 30 TIMES DURING THE PREVIOUS NINE HOURS"; VOMITING "BLACK COFFEE GROUND MATERIAL THAT SMELLED OF FECES." A RE-OPERATION WAS PERFORMED TO REPAIR AN "8MM HOLE" THAT HAD BEEN ¿LEFT BY THE ARM OF THE TROCHAR" CAUSING THE PATIENT¿S BOWEL TO BECOME "HERNIATED AND STRANGULATED." THE PATIENT WAS REPORTED AS STABLE AND THE PATIENT WAS DISCHARGED. IT WAS ALSO ALLEGED THAT A "BROKEN MACHINE" WAS NOT "ADEQUATELY REPAIRED" PRIOR TO THE INITIAL PROCEDURE ON (B)(6) 2019. IT WAS ALSO ALLEGED THAT DURING THE INITIAL PROCEDURE ON (B)(6) 2019, THERE WAS A "NEED TO CONVERT TO AN OPEN PROCEDURE," THERE WERE "ADDITIONAL OR LARGER INCISIONS," THAT THERE WAS ¿EQUIPMENT FAILURE," AND THERE WERE "UNCONTROLLED ELECTRICAL CURRENTS" WITH "PARTS OF THE ROBOT BEING LEFT BEHIND," AND THERE WERE "TISSUE BURNS" DUE TO "THE SURGEON NOT BEING IN TOTAL CONTROL OF THE ROBOT." THE FOLLOWING ADDITIONAL

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED VIA SOCIAL MEDIA (I.E. (B)(6) POST) THAT A PATIENT UNDERWENT AN UNSPECIFIED DA VINCI-ASSISTED ¿BIOPSY¿ PROCEDURE AND ALLEGEDLY EXPERIENCED OPERATIVE COMPLICATIONS. PER THE INITIAL (B)(6) POSTING, THE FOLLOWING WAS NOTED: ¿MY FATHER DIED TWO YEARS AGO WHEN A DAVINCI-AIDED BIOPSY CAUSED MASSIVE BLEEDING. HE MADE ME PROMISE I WOULD NOT SUE. HE DID NOT MAKE ME PROMISE I WOULD NOT TALK ABOUT IT.¿ ON (B)(6) 2019, THE INITIAL REPORTER POSTED THE FOLLOWING SUBSEQUENT (B)(6) POSTING: ¿(B)(6). YOU CAN TAKE IT FROM THERE.¿ REFER TO THE FOLLOWING LINK FOR THE (B)(6) POSTINGS: "(B)(6)".

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED NISSEN FUNDOPLICATION PROCEDURE, A PUNCTURE WOUND WAS FOUND ON THE PATIENT'S SIGMOID COLON. THE PATIENT WAS REPORTEDLY STILL IN THE HOSPITAL. ON (B)(4) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS OBTAINED: THE CSR WAS PRESENT DURING THE DA VINCI-ASSISTED NISSEN FUNDOPLICATION PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. NO INTRA-OPERATIVE COMPLICATIONS WERE IDENTIFIED. THERE WERE ALSO NO REPORTS OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY. ON POST-OPERATIVE DAY #1, THE PATIENT HAD COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR) AND A PUNCTURE WOUND ON THE SIGMOID COLON WAS IDENTIFIED. A BOWEL RESECTION WAS PERFORMED BY A COLORECTAL SURGEON TO ADDRESS THE BOWEL INJURY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE CSR WAS INFORMED THAT THE PATIENT ULTIMATELY EXPIRED. THE CSR SPOKE TO THE SURGEON ABOUT THE POST-OPERATIVE COMPLICATION (I.E. BOWEL INJURY). ACCORDING TO THE CSR, THE SURGEON DID NOT K