BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    MDR report key: 1191163 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03612
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDO
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/10/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, A CLIP EJECTED OUT OF THE DEVICE. THE NEXT FIRING WAS EMPTY AND THEN THE DEVICE FIRED PROPERLY. THEY THEN FINISHED THE PROCEDURE WITH NO OTHER COMPLICATIONS USING THAT DEVICE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL NONE GDO ETHICON ENDO SURGERY, INC. (CINCINNATI) NA C4FF3R

    Patients

    Seq Age Sex Outcome Treatment
    1