BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19746858 · Received July 15, 2024

    Report

    Report Number
    2955842-2024-17009
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    April 25, 2024
    Report Date
    June 20, 2024
    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
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 8MM MARYLAND BIPOLAR FORCEPS INSTRUMENT AND COMPLETED THE DEVICE EVALUATION. THE INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT PROXIMAL END NEAR THE CONNECTOR/MAIN TUBE AND ROLL GEAR JUNCTION. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST. NO SIGNS OF THERMAL DAMAGE WERE OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE 8MM MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT FAILED IN THE MIDDLE OF THE CASE. 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 CUSTOMER REPORTED THAT NO ENERGY WENT THROUGH THE MBF INSTRUMENT WHEN CONNECTED TO THE LEAD, SO A SECOND BIPOLAR LEAD WAS OPENED AND CONNECTED TO THE MBF INSTRUMENT BUT AGAIN NO ENERGY WENT THROUGH THE MBF INSTRUMENT. THE CUSTOMER REPLACED THE MBF INSTRUMENT AND CONNECTED THE LEAD AND EVERYTHING WORKED AS EXPECTED. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NOTHING APPEARED DAMAGED. THE SURGEON ALSO CHECKED THE MBF AFTER IT FAILED, AND NOTHING APPEARED DAMAGED. THE PROCEDURE WAS COMPLETED WITH A BACKUP MBF WITH NO HARM OR INJURY TO THE PATIENT. NO IMAGES OR VIDEOS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718552 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-17 K10221113 0256 00886874119792

    Patients

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