BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 2560659 · Received April 30, 2012

    Report

    Report Number
    MW5025256
    Event Type
    Malfunction
    Date Received
    April 30, 2012
    Date of Event
    February 23, 2012
    Report Date
    April 30, 2012
    Manufacturer
    COVIDIEN SURGICAL DEVICES
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING A LAP CHOLE. PER THE OP REPORT "THE CLIP APPLIER WOULD NOT CLOSE THE CLIPS AFTER BEING FIRED INSIDE THE PT DURING A LAP CHOLE. THIS CLIP APPLIER WAS HANDED OFF THE FIELD AND A NEW ONE OPENED AND USED" DR (B)(6), DR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN ENDO CLIP III AUTO SUTURE FZP COVIDIEN SURGICAL DEVICES ENDO CLIP III CLIP N2A0091X

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR