BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5 MM ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 1811310 · Received August 19, 2010

    Report

    Report Number
    1811310
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ETHICON ENDO-SURGERY LLC
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CLIP APPLIER CLIPS DID NOT CLIP EQUALLY - THE CLIPS WERE UNEVEN WHICH DID NOT LIGATE THE VESSELS/TISSUES CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX 5 MM ENDOSCOPIC MULTIPLE CLIP APPLIER CLIP APPLIER GDO ETHICON ENDO-SURGERY LLC * G4TKOA
    2 LIGAMAX 5 MM ENDOSCOPIC MULTIPLE CLIP APPLIER CLIP APPLIER GDO ETHICON ENDO-SURGERY LLC * G4TKOA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR NO OTHER THERAPIES