BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-CLIP PLA 10MM DISP INSTR 20 CLIPX1

    MDR report key: 1031656 · Received April 14, 2008

    Report

    Report Number
    9615742-2008-00008
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 7, 2008
    Manufacturer
    TREVOUX - USS
    Product Code
    GDO
    PMA / PMN Number
    K032093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 04/14/2008.

    Description of Event or Problem · 1

    PROCEDURE: UNK. ACCORDING TO THE REPORTER: THE INSTRUMENT JAMMED SEVERAL TIMES AND THE CLIPS BROKE. NO PT INJURY. THE OPERATOR USED A DEVICE FROM A DIFFERENT LOT TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-CLIP PLA 10MM DISP INSTR 20 CLIPX1 CLIP APPLIER GDO TREVOUX - USS SHL00144

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK