BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 16883278 · Received May 6, 2023

    Report

    Report Number
    2955842-2023-12625
    Event Type
    Malfunction
    Date Received
    May 6, 2023
    Date of Event
    September 15, 2020
    Report Date
    January 19, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111475
    PMA / PMN Number
    K050369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE REPORTED FAILURE. THE INSTRUMENT WAS RETURNED AND FAILURE ANALYSIS (FA) FOUND A BROKEN CONDUCTOR WIRE AT THE YAW PULLEY EXIT. THE WIRE WAS DETACHED FROM ITS CONNECTION AT THE GRIP. THE YAW PULLEY SHOWED NO SIGNS OF ARCING. DUE TO THE BROKEN CONDUCTOR WIRE, THE ELECTRICAL CONTINUITY TEST WAS NOT REQUIRED. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO A COMPONENT FAILURE. THE INSTRUMENT WAS ALSO FOUND TO HAVE INSULATION DAMAGE ON THE CONDUCTOR WIRE. APPROXIMATELY .008" X .011" WAS BROKEN OFF AND WAS NOT RETURNED. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO A COMPONENT FAILURE. THERE WERE NO SIGNS OF ARCING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT, THE CABLE BROKE. A SIMILAR BACKUP DA VINCI INSTRUMENT WAS USED TO CONTINUE WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555951 ENDOWRIST;DAVINCI SI MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 420172-17 N10191014 394 00886874111475

    Patients

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