BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20783363 · Received November 26, 2024

    Report

    Report Number
    2955842-2024-22437
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    October 29, 2024
    Report Date
    November 4, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT ASSOCIATED WITH THE CUSTOMER-REPORTED COMPLAINT. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL BENIGN HYSTERECTOMY PROCEDURE, THE 8MM MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT HAD INTRAOPERATIVE CABLE BREAKAGE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: A BACKUP INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO FRAGMENT FELL INTO THE PATIENT'S ANATOMY. IT IS NOT KNOWN IF THE OPERATION WAS DELAYED DUE TO THIS PROBLEM. THE INSTRUMENT AND THE ASSOCIATED ACCESSORY ARE AVAILABLE FOR RETURN TO ISI FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2434557 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K10230713 0046 00886874119815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DA VINCI INSTRUMENTS AND ACCESSORIES