BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 17982177 · Received October 22, 2023

    Report

    Report Number
    2955842-2023-19488
    Event Type
    Malfunction
    Date Received
    October 22, 2023
    Date of Event
    August 17, 2023
    Report Date
    September 26, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114339
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS AND THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAS BEEN EVALUATED BY THE ADVANCE ENGINEERING TEAM. THE INSTRUMENT EXHIBITED A BROKEN MOLDED INSULATOR, WHICH HAS RESULTED THE GRIP TIP BECOMING DISLODGED. NEITHER THE MOLDED INSULATOR FRAGMENT NOR THE GRIP TIP WERE RETURNED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND THE REPORTED FAILURE WAS CONFIRMED. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN MOLDED INSULATOR. THE BROKEN PIECE WAS FOUND COMPLETELY DETACHED FROM THE DISTAL TIP AND WAS NOT RETURNED WITH THE INSTRUMENT. THE MISSING PIECE MEASURED APPROXIMATELY 0.155" X 0.363" IN SIZE. ADDITIONAL OBSERVATIONS NOT REPORTED BY THE SITE WERE ALSO IDENTIFIED. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED GRIP TIP. THE DISLODGED GRIP TIP, MEASURING APPROXIMATELY 0.192" X 0.597" IN SIZE, WAS NOT RETURNED WITH THE INSTRUMENT. THE BROKEN MOLDED INSULATOR RESULTED IN THE GRIP TIP BECOMING DISLODGED. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE GRIP-CRIMP LOCATION. THE WIRE INSULATION WAS NOT DAMAGED, AND THE INSTRUMENT FAILED AN ELECTRICAL CONTINUITY TEST. NO THERMAL DAMAGE WAS OBSERVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT'S JAW WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER BELIEVES THAT THE JAW OF THE INSTRUMENT WAS NOT OPENING OR CLOSING CORRECTLY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1962132 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-57 U10221111 0022 00886874114339

    Patients

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