BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5

    MDR report key: 2213783 · Received August 11, 2011

    Report

    Report Number
    2213783
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 11, 2011
    Manufacturer
    ETHICON ENDOSCOPY SURGERY
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    A 5MM CLIP APPLIER MISFIRED. FIRST THREE CLIPS WERE IN A HORSE SHOE SHAPE. THE NON-OCCLUSIVE STAPLES LEFT PATIENT WITH A BLEEDING VESSEL. NEW CLIP APPLIER OPENED AND ADDED TO THE FIELD. PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT. MALFUNCTION CLIP APPLIER REMOVED FROM FIELD AND SAVED WITH PACKAGING FOR RETURN TO VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX 5 CLIP APPLIER FZP ETHICON ENDOSCOPY SURGERY * H4425A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR