BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP M/L

    MDR report key: 5643891 · Received May 10, 2016

    Report

    Report Number
    1219930-2016-00422
    Event Type
    Injury
    Date Received
    May 10, 2016
    Date of Event
    April 5, 2016
    Report Date
    April 14, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    FZP
    UDI-DI
    10884521057852
    PMA / PMN Number
    K071406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. VISUAL INSPECTION OF THE INSTRUMENT NOTED THE HANDLE WAS FLACCID AND NOT ATTACHED TO THE INTERNAL COMPONENTS. A PARTIALLY FORMED CLIP WAS LOCKED IN THE JAWS. THE INSTRUMENT WAS DISMANTLED FOR VISUALIZATION OF INTERNAL COMPONENTS WHICH REVEALED THAT THE WISHBONE LINK WHICH ATTACHES THE TRIGGER TO THE FIRING MECHANISM HAD DISENGAGED. THE WISHBONE LINK WAS REATTACHED TO THE TRIGGER HANDLE AND THE INSTRUMENT WAS REASSEMBLED. THE INSTRUMENT WAS THEN FOUND TO CYCLE WITHOUT BINDING. TEN CLIPS LOADED INTO THE JAWS, FORMED PROPERLY, RELEASED FROM THE JAWS AND REMAINED SECURELY ATTACHED TO TEST MEDIA. WHEN THE CARTRIDGE WAS EMPTY, THE INTERLOCK ENGAGED TO PREVENT THE JAWS FROM APPROXIMATING. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AMENDED AS NEEDED. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS CANNOT RELEASE THE TISSUE. THE SURGEON COULD NOT SQUEEZE THE HANDLE OF THE DEVICE. THE CLIPS WERE NOT ABLE TO PROPERLY LOAD INTO THE JAWS AND BE FIRED CORRECTLY. THE CLIPS DID NOT FORM CORRECTLY. THE PROCEDURE WAS CHANGED FROM LAPAROSCOPIC TO OPEN. THE OPERATING TIME WAS EXTENDED BY MORE THAN THIRTY MINUTES. THE PATIENT HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299851 ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP M/L CLIP, IMPLANTABLE FZP COVIDIEN, FORMERLY US SURGICAL A DIVISON 176630 N5E0910MX 10884521057852

    Patients

    Seq Age Sex Outcome Treatment
    1 Other