BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 18490418 · Received January 11, 2024

    Report

    Report Number
    2955842-2024-10230
    Event Type
    Death
    Date Received
    January 11, 2024
    Date of Event
    November 16, 2023
    Report Date
    December 15, 2023
    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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OF ANY MALFUNCTION OF AN INTUITIVE DAVINCI SYSTEM, INSTRUMENT OR ACCESSORY OCCURRING DURING THE PROCEDURE; NO PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION. THE INSTRUMENTS NOTED BELOW WERE USED DURING THE REPORTED PROCEDURE. REVIEW OF THE INSTRUMENT LOGS FOUND THAT THE FOLLOWING MULTIPLE USE INSTRUMENTS WERE USED IN SUBSEQUENT PROCEDURES AFTER THE EVENT DATE WITH NO REPORTED COMPLAINTS: ENDOSCOPE 0 DEGREE CAMERA, ENDOSCOPE 30 DEGREE CAMERA, MONOPOLAR CURVED SCISSORS, CADIERE FORCEPS. THE FORCEPS BIPOLAR WITH DUAL GRIP HAS LIVES REMAINING BUT HAS NOT BEEN USED IN SUBSEQUENT PROCEDURES. REVIEW OF THE SYSTEM LOGS FOUND NO RELEVANT ERRORS LOGGED DURING THE PROCEDURE. MULTIPLE PROCEDURES HAVE BEEN PERFORMED ON THIS SYSTEM AND REVIEW OF THE LOGS FOR THE SUBSEQUENT 5 PROCEDURES ALSO FOUND NO RELEVANT ERRORS. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DEVICE(S) INVOLVED WITH THE REPORTED EVENT CONFIRMED THERE WERE NO NON-CONFORMANCES RELATED TO THIS COMPLAINT. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT THE CAUSE OF DEATH WAS MASSIVE BLEEDING WHICH REPORTEDLY OCCURRED AFTER THE ROBOT WAS UNDOCKED AND DURING REMOVAL OF THE SPECIMEN. THE CAUSE OF THE BLEEDING, WHICH VESSEL BLED, AND THE DETAILS SURROUNDING THE EVENT ARE UNKNOWN. BASED ON THE INFORMATION PROVIDED, THERE IS INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHROURETERECTOMY SURGICAL PROCEDURE FOR A MALIGNANT TUMOR OF THE URETER, THE PATIENT EXPERIENCED EXCESSIVE BLEEDING AND EXPIRED ON THE DAY OF SURGERY. THE RESECTION OF THE KIDNEY AND URETER WAS COMPLETED AND THE DAVINCI SYSTEM WAS ¿ROLLED OUT¿. THE MASSIVE BLEEDING OCCURRED WHEN THE RESECTED KIDNEY WAS REMOVED FROM THE BODY PRIOR TO WOUND CLOSURE. INFORMATION REGARDING THE CAUSE, SPECIFIC LOCATION, AND ANY INTERVENTIONS PERFORMED FOR THE OBSERVED BLEEDING WAS NOT KNOWN BY THE REPORT SOURCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002323 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES