BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP APPLIER WITH CLIP LOGIC TECHNOLOGY

    MDR report key: 3370487 · Received September 23, 2013

    Report

    Report Number
    MW5031993
    Event Type
    Malfunction
    Date Received
    September 23, 2013
    Date of Event
    September 11, 2013
    Report Date
    September 11, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STAPLER MISFIRED EACH AFTER REP FOR COVIDIEN CONFIRMED THEY WERE LOADED AND FIRED PROPERLY. HIS THOUGHT WAS "THE TISSUE WAS TOO THICK." STAPLERS WERE BEING FIRED IN LOCATION NECESSARY TO PERFORM PROCEDURE OF SLEEVE GASTRECTOMY WHERE STOMACH IS KNOWN TO BE THICK. ALSO WHEN RETICULATED STAPLER WOULD CUT STRING ON SEAMGUARD STAPLE LINE REINFORCEMENT. 140291-2013-00019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479223 CLIP APPLIER WITH CLIP LOGIC TECHNOLOGY ENDO CLIP III AUTO SUTURE FZP COVIDIEN N3G0001MX

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR