BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTICULATOR ENDO GRASP 5MM W/SPIN LOCK

    MDR report key: 1900924 · Received November 9, 2010

    Report

    Report Number
    2647580-2010-00886
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K914753
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP GASTRIC BANDING. ACCORDING TO THE REPORTER: AFTER REMOVING THE SHAFT, THE STAFF NOTICED THAT THE SHAFT SPLIT AFTER APPLYING OVER TISSUE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC AND THERE WAS NO UNANTICIPATED TISSUE LOSS. THE CASE 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 GCJ USSC PUERTO RICO P0G0251

    Patients

    Seq Age Sex Outcome Treatment
    1