BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16971162 · Received May 21, 2023

    Report

    Report Number
    2955842-2023-13832
    Event Type
    Malfunction
    Date Received
    May 21, 2023
    Date of Event
    September 20, 2021
    Report Date
    September 20, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119792
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE INSTRUMENT WAS FOUND WITH THERMAL DAMAGE AT THE YAW PULLEY. BLACK CHAR MARKS WERE OBSERVED. ANY MATERIAL MISSING IS LIKELY TO BE THERMALLY INDUCED RATHER THAN MECHANICALLY INDUCED. THIS FAILURE IS TYPICALLY ASSOCIATED WITH MISHANDLING/MISUSE. THE ELECTRICAL CONTINUITY TEST STILL PASSED AND THERE WAS NO INSULATION DAMAGE OBSERVED TO THE CONDUCTOR WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT RUBBER IS BURNT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO REPORT OF ARCING NOR PATIENT INJURY. THE INSTRUMENT WAS BROUGHT TO HER FROM CENTRAL PROCESSING WITH NO ADDITIONAL INFORMATION NOR POINT OF CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741617 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-16 N11210419 0403 00886874119792

    Patients

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