BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTICULATOR ENDO DISSECT 5MM INSTRUMENT

    MDR report key: 1811136 · Received August 13, 2010

    Report

    Report Number
    2647580-2010-00701
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 26, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K914753
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: THE SHAFT WAS TORN PART AT THE DISTAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTICULATOR ENDO DISSECT 5MM INSTRUMENT DISPOSABLE SURGICAL ACCESSORY GCJ USSC PUERTO RICO P9E0394

    Patients

    Seq Age Sex Outcome Treatment
    1