BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    MDR report key: 1190829 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03505
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 15, 2008
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NEPHRECTOMY PROCEDURE, THE DEVICE WAS LOCKED ON A VEIN. THE DEVICE WAS OPENED AND REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO ADVERSE 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 FZP ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4GC2Z

    Patients

    Seq Age Sex Outcome Treatment
    1