BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1053126 · Received May 12, 2008

    Report

    Report Number
    1527736-2008-02936
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HAND ASSISTED RIGHT NEPHRECTOMY, THE CLIP DEPLOYED BUT DEVICE WOULD NOT RELEASE FROM THE TISSUE. THE SURGEON HAD TO PULL THE DEVICE OFF, TEARING THE TISSUE. A VASCULAR STAPLER WAS USED MULTIPLE TIMES TO STOP THE BLEEDING AND DIVIDE THE TISSUE. IT IS UNK HOW MUCH BLOOD LOSS, BUT THERE IS NO NOTATION OF ANY TYPE OF BLOOD PRODUCTS BEING USED. THE SITE WAS STILL OOZING AFTER COMPLETION SO THE SURGEON REINSERTED THE PORTS TO ENSURE THE AREA HAD NOT REOPENED. ONCE HE HAD PULLED IT OFF AND REMOVED IF FROM THE BODY, HE WAS THEN ABLE TO PULL HARD ENOUGH TO OPEN THE TRIGGER. AS THE JAWS OPENED, HE WAS UNABLE TO SEE IF A CLIP HAD BEEN IN THE JAWS. THERE WERE NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO SURGERY, INC. (CINCINNATI) NA E4KC2L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other