BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP

    MDR report key: 1925126 · Received November 29, 2010

    Report

    Report Number
    1925126
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FIRST TWO USES THE DEVICE WORKED AS IT SHOULD. ON THE THIRD ATTEMPT TO USE, THE DEVICE FAILED TO FIRE AND JAMMED. NO PATIENT HARM. NEW DEVICE WAS USED (SAME TYPE) TO FINISH PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ROTATING MULTIPLE CLIP APPLIER GDO ETHICON ENDO-SURGERY 10 MM G4TX5P

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR