BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 19210750 · Received April 30, 2024

    Report

    Report Number
    2955842-2024-14002
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    March 28, 2024
    Report Date
    April 2, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114322
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SINGLE-PORT MARYLAND BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM THE REPORTED COMPLAINT. FOR CLARIFICATION, THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE TO THE MOLDED INSULATOR. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CUSTOMER IDENTIFIED UNDER MAGNIFICATION, A CHIPPED PORTION ON THE JAW OF THE SINGLE-PORT MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS OBSERVED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THIS DEVICE ISSUE WAS IDENTIFIED IN THE CENTRAL PROCESSING UNIT (CPU) DURING ASSEMBLY. THIS WAS SOLELY THE OBSERVATION OF THE PROCESSING STAFF AND WAS BEING REPORTED WITH AN ABUNDANCE OF CAUTION. IT WAS POSSIBLE THAT IT COULD HAVE HAPPENED IN THE CPU. THE SURGICAL TEAM DID NOT REPORT ANYTHING WRONG WITH THE INSTRUMENT DURING ITS USE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080490 ENDOWRIST SP MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430010-57 U10221107 0013 00886874114322

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES.