BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC CLIP APPLIER

    MDR report key: 1053037 · Received May 16, 2008

    Report

    Report Number
    1053037
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    March 31, 2008
    Report Date
    May 16, 2008
    Manufacturer
    ETHICON ENDOSURGERY INC.
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE PHYSICIAN NEEDED TO CLIP VESSELS WITH ETHICON 10 MM CLIP APPLIER, BUT THE CLIP APPLIER MIS-FIRED. HE TRIED TO RELEASE CLIP WITH ANOTHER SURGICAL INSTRUMENT (HEMOCLIP) BUT TRIED TO FIRE CLIP APPLIER AND THE HANDLE WOULD NOT SQUEEZE TOGETHER. NEW CLIP APPLIER RETRIEVED AND OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAROSCOPIC CLIP APPLIER CLIP APPLIER GDO ETHICON ENDOSURGERY INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR