BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTICULATOR ENDO GRASP 5MM W/SPIN LOCK

    MDR report key: 1853971 · Received September 29, 2010

    Report

    Report Number
    2647580-2010-00802
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    July 16, 2010
    Report Date
    September 6, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GET
    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 DISTAL BLACK SHAFT BROKE. NOTHING FELL INTO THE PT'S CAVITY. OPERATIVE TIME WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTICULATOR ENDO GRASP 5MM W/SPIN LOCK DISPOSABLE SURGICAL DEVICE GET USSC PUERTO RICO P9G0026

    Patients

    Seq Age Sex Outcome Treatment
    1