BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 23550847 · Received November 13, 2025

    Report

    Report Number
    2955842-2025-45214
    Event Type
    Death
    Date Received
    November 13, 2025
    Date of Event
    October 15, 2025
    Report Date
    February 2, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO ALLEGATION AGAINST A DA VINCI PRODUCT ASSOCIATED WITH THIS EVENT, THEREFORE; NO PRODUCT WAS RETURNED FOR FAILURE ANALYSIS INVESTIGATION. REVIEW OF THE INTRAOPERATIVE SYSTEM LOGS FOUND THAT FOR THE DURATION OF THE PROCEDURE THE SYSTEM FUNCTIONED NORMALLY AND THERE WERE NO INDICATIONS RELATING TO THIS EVENT. THE SYSTEM LOGS CANNOT CAPTURE OR SHOW ANY LAPAROSCOPIC THIRD-PARTY STAPLER RELATED ACTIVITIES. IT IS UNDETERMINABLE WHEN THE THIRD-PARTY LAPAROSCOPIC DEVICE WAS IN USE DURING THE ROBOTIC PORTION OF THE PROCEDURE. REVIEW OF THE FIVE SUBSEQUENT PROCEDURES PERFORMED ON THIS SYSTEM FOUND IT WAS FUNCTIONING NORMALLY WITH NO INTRAOPERATIVE EVENTS OR ISSUES. THE FOLLOWING CONCOMITANT PRODUCTS WERE USED DURING THIS PROCEDURE: TWO 30 DEGREE ENDOSCOPE PLUSES, MONOPOLAR CURVED SCISSORS, TIP-UP FENESTRATED GRASPER, LARGE NEEDLE DRIVER, FENESTRATED BIPOLAR FORCEPS. A SITE HISTORY REVIEW FOUND NO COMPLAINTS WERE MADE FOR THE INSTRUMENTS USED DURING THIS PROCEDURE. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE PATIENT IN THIS REPORT WAS UNDERGOING A ROBOTIC PARTIAL LEFT NEPHRECTOMY AND A 3RD PARTY STAPLER WAS USED IN AN ATTEMPT TO TRANSECT THE RENAL VESSELS. ALTHOUGH THE PROCEDURE WAS COMPLETED, THE PATIENT BECAME ILL SOON AFTER AND THE SMALL BOWEL WAS NOTED TO BE DEAD ON RE-EXPLORATION. THE PATIENT LATER EXPIRED FROM THIS COMPLICATION. IT WAS LATER REVEALED THE PATIENT HAD A STAPLER INJURY TO THE SUPERIOR MESENTERIC ARTERY. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, NO INTUITIVE SURGICAL PRODUCT OR INSTRUMENT CONTRIBUTED TO THIS EVENT. SECTION A2: THE PATIENT'S EXACT AGE WAS NOT PROVIDED, BUT WAS STATED TO BE "AROUND 50 YEARS OLD". SECTION B2 DATE OF DEATH: THE PATIENT'S DATE OF DEATH WAS NOT PROVIDED BUT IS ESTIMATED TO BE BETWEEN POSTOPERATIVE DAYS 1 AND DAY 7.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION OBTAINED FROM LEGAL DOCUMENTS RECEIVED ON 07-JAN-2026: ¿DURING SURGERY, THE [PATIENT¿S] SUPERIOR MESENTERIC ARTERY AND CELIAC ARTERY WERE SEVERED WHICH REDUCED THE BLOOD SUPPLY TO BOTH HIS LARGE AND SMALL BOWEL AND LIVER. THE TRANSECTION OF THESE TWO MAIN ARTERIES WENT UNRECOGNIZED, AND [PATIENT] WAS ADMITTED TO THE POST ANESTHESIA CARE UNIT (¿PACU¿) AND THEN SENT TO A TELEMETRY POST-SURGICAL ROOM WHERE HE INITIALLY SHOWED NORMAL LEVEL VITAL SIGNS, INCLUDING BLOOD PRESSURE AND PULSE.¿ LATER IN THE EVENING, THE LEGAL DOCUMENT STATES, "[PATIENT] COMPLAINED OF SEVERE ABDOMINAL PAIN AND SHOWED DIMINISHED BOWEL SOUNDS.¿ LATER, THE ¿[PATIENT] SHOWED SEVERE HYPOTENSION¿ ¿¿ DETERIORATING CONDITION¿WHEN A CODE BLUE WAS CALLED FOR CARDIOPULMONARY ARREST¿.¿ CT SCAN SHOWED POSSIBLE TRANSECTION OF THE SUPERIOR MESENTERY ARTERY.¿ AND ¿ALSO TRANSECTION OF THE CELIAC TRUNK.¿ THE LEGAL DOCUMENT STATES, ¿VASCULAR SURGEONS¿WERE INVOLVED TO PERFORM A BYPASS SURGERY TO RE-VASCULARIZE BOTH THE SUPERIOR MESENTERIC ARTERY AND THE CELIAC ARTERY.¿ THE NEXT DAY, THE [PATIENT] WAS ¿RETURNED TO SURGERY WHERE THEY OBSERVED AN ISCHEMIC BOWEL AND NECROTIC GALL BLADDER¿.¿ THE PATIENT DIED LATER THAT DAY.¿ ¿AN AUTOPSY CONFIRMED THE [PATIENT] DIED FROM EXCESSIVE BLOOD LOSS WHICH OCCURRED AS A RESULT OF HIS NEPHRECTOMY SURGERY¿¿. SECTION A2 PATIENT AGE UPDATED TO 51YEARS FORM ESTIMATED 50 YEARS. SECTION B2 DATE OF DEATH ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PARTIAL LEFT NEPHRECTOMY, THE PATIENT CODED AT AN UNSPECIFIED TIME POST-PROCEDURE AND REQUIRED A SECONDARY PROCEDURE. THE PATIENT EXPIRED AT AN UNSPECIFIED TIME LATER. THE INTUITIVE CLINICAL SALES ASSOCIATE (CSA) WHO WAS PRESENT DURING THE LAST HALF OF THE PROCEDURE REPORTED THAT DURING THE SURGEON USED AN UNSPECIFIED THIRD-PARTY LAPAROSCOPIC STAPLER TO PERFORM ALL STAPLER FIRES REQUIRED FOR THE PROCEDURE. NO INTUITIVE STAPLER INSTRUMENTS WERE USED. IT WAS NOTED THAT THERE WAS DIFFICULTY USING GETTING THE PROPER ANGLE WITH THE LAPAROSCOPIC STAPLERS. WHILE PERFORMING THE EXTRA-CORPOREAL STAPLER FIRES. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE CSA WAS INFORMED LATER THAT THE PATIENT CODED AFTER THE INDEX PROCEDURE AND UNDERWENT A SECONDARY PROCEDURE THAT LASTED 12 HOURS AND THAT BOWEL INFLAMMATION WAS OBSERVED, AND THE PATIENT'S ¿SMALL BOWEL WAS POSSIBLY DEAD.¿ NO INFORMATION REGARDING WHAT SPECIFIC SURGICAL INTERVENTION WAS PERFORMED; IT WAS STATED THAT THE PATIENT WAS ¿LEFT OPEN¿ AND TAKEN TO THE INTENSIVE CARE UNIT (ICU). ON POST-OPERATIVE DAY 7 THE CSA WAS INFORMED BY THE SURGEON WHO PERFORMED THE SECOND EXPLORATORY PROCEDURE THAT THE PATIENT HAD EXPIRED. THE CAUSE OF DEATH WAS A COMPLICATION RELATED TO THE THIRD-PARTY STAPLER FIRE ON THE SUPERIOR MESENTERIC ARTERY (SMA) DURING THE INDEX PROCEDURE. THE SURGEON DID NOT PROVIDE THE DATE OF DEATH OR ANY ADDITIONAL INFORMATION REGARDING THE NATURE OF THE STAPLE LINE ISSUE OR THE SECONDARY SURGERY THAT WAS PERFORMED. FOLLOW-UP ATTEMPTS TO SPEAK WITH THE SURGEONS HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922981 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Death| R DA VINCI INSTRUMENTS AND ACCESSORIES.