BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTICULATOR ENDO GRASP 5MM W/SPIN LOCK

    MDR report key: 1932826 · Received December 2, 2010

    Report

    Report Number
    2647580-2010-00939
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    July 30, 2010
    Report Date
    September 6, 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: LAP CHOLE. ACCORDING TO THE REPORTER: THE TOP OF THE DEVICE BROKE, THE BLACK OUTER SHEATH. NOTHING FELL INTO THE PT'S CAVITY. OPERATIVE TIME WAS NOT EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTICULATOR ENDO GRASP 5MM W/SPIN LOCK DISPOSABLE SURGICAL ACCESSORY GCJ USSC PUERTO RICO P9E0021

    Patients

    Seq Age Sex Outcome Treatment
    1