BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTICULATOR ENDO DISSECT 5MM INSTRUMENT

    MDR report key: 1932834 · Received December 2, 2010

    Report

    Report Number
    2647580-2010-00940
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GET
    PMA / PMN Number
    K914753
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: BY PREPARATION FOR SURGERY, WHEN THE OPERATOR TRIED TO ROTATE THE HANDLE TO FIX THE ANGLE OF THE DEVICE, PART OF RESIN CAME OFF BECAUSE PART OF THE SHAFT WAS SCRATCHED. THE DEVICE WAS NOT USED FOR PT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTICULATOR ENDO DISSECT 5MM INSTRUMENT DISPOSABLE SURGICAL ACCESSORY GET USSC PUERTO RICO P0B0918

    Patients

    Seq Age Sex Outcome Treatment
    1