BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY, INC.

    MDR report key: 1238921 · Received November 18, 2008

    Report

    Report Number
    MW5009050
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    November 2, 2008
    Report Date
    November 18, 2008
    Manufacturer
    ETHICON
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LIGAMAX ENDO CLIP APPLIER WOULD NOT RELEASE STAPLES. PT IN SURGERY AND NEEDED DEVICE FOR CONTROL OF BLEEDING. NEW APPLIER OPENED AND USED. NO HARM TO PT. DIAGNOSIS OR REASON FOR USE: TO STOP BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC. LIGAMAX 5 MM ENDOSCOPIC MULTIPLE CLIP APPLIER KOG ETHICON E15ML E4M30U

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other