BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTICULATOR ENDO DISSECT 5MM INSTRUMENT

    MDR report key: 1900923 · Received November 9, 2010

    Report

    Report Number
    2647580-2010-00884
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 11, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    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

    PROCEDURE: LAP CHOLE. ACCORDING TO THE REPORTER: BY PREPARATION FOR SURGERY, IT WAS FOUND THAT THE COVER ON THE CLEAR SHAFT PART HAD COME OFF. THE DEVICE WAS NOT USED ON THE PATIENT AFTER THE INCIDENT. THE STAFF USED ANOTHER DEVICE TO COMPLETE THE CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1