BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM- LARGE TITANIUM LIG

    MDR report key: 1821131 · Received August 9, 2007

    Report

    Report Number
    1527736-2007-05264
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Date of Event
    July 25, 2007
    Report Date
    July 27, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, WHEN FIRING THE DEVICE THE CLIP EJECTED AND COULD NOT BE CLOSED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM- LARGE TITANIUM LIG FZP ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4GJ7V

    Patients

    Seq Age Sex Outcome Treatment
    1