BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX5

    MDR report key: 1811274 · Received August 16, 2010

    Report

    Report Number
    1811274
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE SURGEON ATTEMPTED TO APPLY 5MM SURGICAL LIGACLIP WHEN CLIP APPLIER DEVICE JAMMED AND GOT STUCK ON THE TISSUE.====================== MANUFACTURER RESPONSE FOR ENDOSCOPIC MULTIPLE CLIP APPLIER, LIGAMAX5======================MFG ASSIGNED INCIDENT NUMBER AND ADVISED THAT I WOULD SHIP DEVICE AS SOON AS I RECEIVED SHIPPING INFORMATION. INFORMED MFG THAT WE WOULD TRY TO PROVIDE THEM WITH FOLLOW UP INFORMATION AS REQUESTED BY MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX5 CLIP APPLIER GDO ETHICON ENDO-SURGERY * G4TD1J

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR