BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 17244022 · Received June 30, 2023

    Report

    Report Number
    2955842-2023-16744
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    May 3, 2023
    Report Date
    May 31, 2023
    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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS FURTHER INVESTIGATED AND FOUND THE INSTRUMENT TO HAVE A BROKEN MOLDED INSULATOR. THE MOLDED INSULATOR BROKE AND NONE OF THE PIECES WERE RETURNED WITH THE INSTRUMENT. THE MOLDED INSULATOR SECURES THE GRIP SUBASSEMBLY TO THE OVERALL GRIP SET, AND IF IT BREAKS COMPLETELY THE GRIP CAN BECOME DISLODGED. THIS INSTRUMENT ALSO APPEARS TO HAVE A BROKEN BIPOLAR WIRE AT THE DISTAL END AND MAY HAVE BROKEN DURING THE SAME EVENT WHERE THE MOLDED INSULATOR BROKE, AND THE GRIP BECAME DISLODGED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP AT THE GRIP BASE. A PIECE APPROXIMATELY 0.168" X 0.598" WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED. THE COMPLAINT REGARDING THE INSTRUMENT BEING BROKEN WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT HAD ONLY ONE USE LEFT AND WAS BROKEN. THERE WERE NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26327 ENDOWRIST SP MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430010-57 U10220908 0010 00886874114322

    Patients

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