At 6:35 p.m. on November 3, 2021, an employee was performing maintenance work on a machine in the automotive engine parts manufacturing facility. As the employee performed maintenance on the tool brush inside the deenergized machine, his upper body was protruding through the part entry door on top of the machine. While working in this position, the energized gantry robot which moves parts to and from the individual machines across the crank shaft line, entered the employee's work zone and struck him. The employee was entangled and caught between the gantry's "grabber hand" and the side of the machine. The employee suffered fatal injuries due to entanglement at the waist level by the gantry and the inside of the machine causing bleeding, contusions, lacerations, and bruises in the upper arms, chest, head and rib cage areas.

ExcelsiusGPS — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AN EXCELSIUS ROBOT WAS IN USE WHEN A PATIENT EXPERIENCED ADVERSE HEALTH EFFECTS AND PASSED AWAY.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 30-AUG-2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN UPDATES IN SURGERY ARTICLE TITLED, ¿IMPACT OF BODY MASS INDEX ON THE EARLY EXPERIENCE OF ROBOTIC PANCREATICODUODENECTOMY¿ (CHAO, Y. J., LIAO, T. K., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: "ALL OPERATIONS WERE PERFORMED USING THE DA VINCI SI SURGICAL SYSTEM. TWO PATIENTS (2.9%) WERE CONVERTED TO OPEN SURGERY IN THE OBESE GROUP DUE TO SEVERE INFLAMMATION AT THE PANCREATIC HEAD AND TUMOR ADHESIVE TO THE SUPERIOR MESENTERIC VEIN AND NONE IN THE NORMAL-WEIGHT AND OVERWEIGHT GROUPS. THIRTY THREE PATIENTS EXPERIENCED COMPLICATIONS WITH AN OVERALL COMPLICATION RATE OF 51.5%, AND THE MAJOR COMPLICATION RATE (CLAVIEN GRADE = III) WAS 19.1%. THERE WERE 17.6% CLINICALLY RELEVANT POST-OPERATIVE PANCREATIC FISTULA (CR-POPF) (16.1% GRADE B POPF, 1.5% GRADE C POPF), 8.9% GRADE B/C POST PANCREATECTOMY HEMORRHAGE (PPH), 11.8% GRADE B/C DELAYED GASTRIC EMPTYING (DGE), AND 5.9% BILE LEAKAGE. TWELVE PATIENTS (17.6%) HAD PERIPANCREATIC FLUID COLLECTIONS, AND EIGHT OF THEM REQUIRED DRAINAGE. ONE PATIENT REQUIRED REOPERATION DUE TO FAILED EMBOLIZATION OF THE PSEU

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 BY AN UNSPECIFIED SURGEON, NOT THE CONSOLE SURGEON OF RECORD, THAT THERE WAS A REPORT OF A PATIENT DEATH OCCURRING ON AN SP DA VINCI SYSTEM. ADDITIONAL EVENT DETAILS (INCLUDING THE DATE OF THE EVENT), PATIENT DEMOGRAPHICS, PATIENT DATE OF DEATH, AND SYSTEM AND/OR PROCEDURE DETAILS WERE UNKNOWN AND UNATTAINABLE EVEN AFTER ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION. INTUITIVE SURGICAL, INC. (ISI) HAS REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT HAD A MILD HERNIA THAT NEEDED REPAIR. IT WAS DONE ROBOTICALLY USING THE DAVINCI SYSTEM. THE PATIENT HAD A PUNCTURED ARTERY AND A LACERATED BOWEL FROM SURGICAL ERRORS DURING THE PROCEDURE. THERE WAS EXTENSIVE INTERNAL BLEEDING. THE PATIENT BECAME SEPTIC AND WITHIN THREE DAYS WAS DEAD. THE PATIENT WAS HEALTHY WHEN HE WALKED IN EVEN THOUGH HE WAS AN OLDER PATIENT. THE PATIENT WENT TO THE HOSPITAL WITH UPPER ABDOMINAL PAIN. IT WAS DETERMINED HE HAD A HERNIA AND HE WAS SENT TO A DOCTOR TO HAVE IT REPAIRED. FDA SAFETY REPORT ID # (B)(4).

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 5-MAY-2021, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5100203 STATING: ¿A (B)(6) Y/O FEMALE WITH A HISTORY OF 12DM. HTN. UTERINE ADENO CANCER S/P HYSTERECTOMY (2016), HX OF APPENDICEAL ADENOMA SEEN ON ENDOSCOPY THAT WAS SUSPICIOUS FOR MALIGNANCY UNDERWENT A ROBOTIC ASSISTED LAP RIGHT HEMICOLECTOMY ON (B)(6) 2021. ON (B)(6) 2021 THE PATIENT BECAME HYPOXIC AND CARDIAC ARRESTED. THE PATIENT UNDERWENT THREE ROUNDS OF CPR BEFORE OBTAINING ROSC. THE PATIENT WAS TRANSPORTED TO ICU, AND THREE UNITS OF EMERGENCY RELEASED PRSCS WERE TRANSFUSED, DUE TO A PROFOUND DROP IN HER HGB, THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AND A DECISION WAS MADE TO RETURN TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY. IN THE OPERATING ROOM, THE ILEOCOLIC ARTERY WAS FOUND TO HAVE A PULSATILE BLEED AND WAS SUBSEQUENTLY LIGATED. ON RETURN TO THE ICU, PT. REMAINED HEMODYNAMICALLY UNSTABLE WITH WORSENING HYPOXIA. THE PATIENT REQUIRED INCREASED PRESSURE SUPPORT THROUGHOUT THE DAY. ON (B)(6) 2021 THE PATIENT¿S CONDITION CONTINUED TO WORSEN. ABDOMINAL COMPARTMENT SYNDROME WAS SUSPECTED AND THE DECISION WAS MADE BY THE ICU TEAM TO RE-OPEN THE ABDOMEN AT THE BEDSIDE. UPON ENTRY INTO THE ABDOMEN, 1000 CCS OF