BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-CLIP PLA 10MM DISP INSTR 20 CLIPX1

    MDR report key: 1071817 · Received July 8, 2008

    Report

    Report Number
    9615742-2008-00025
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    May 5, 2008
    Report Date
    July 1, 2008
    Manufacturer
    TREVOUX - USS
    Product Code
    GDO
    PMA / PMN Number
    K032093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LAP APPENDECTOMY. ACCORDING TO THE RPTR: WHILE USING THE I-CLIP, INSTRUMENT THE CLIPS FELL OUT OF THE INSTRUMENT AND INTO THE PT CAVITY AND WERE RETRIEVED WITH A 15 MINUTE DELAY IN OR TIME. THE PROCEDURE WAS COMPLETED WITH ANOTHER INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-CLIP PLA 10MM DISP INSTR 20 CLIPX1 DISPOSABLE CLIP APPLIER GDO TREVOUX - USS SHJ00340

    Patients

    Seq Age Sex Outcome Treatment
    1