BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1584162 · Received January 25, 2010

    Report

    Report Number
    3005075853-2010-00288
    Event Type
    Malfunction
    Date Received
    January 25, 2010
    Date of Event
    January 4, 2010
    Report Date
    January 4, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VIDEO ASSISTED THORACOSCOPY SURGERY, SIX OF THE DEVICES PRODUCED CRISS-CROSSED CLIPS, FED TWO CLIPS AT A TIME, FED CLIPS SIDEWAYS AND CLIPS CAME OUT MALFORMED ON SEVERAL FIRINGS. THE SEVENTH DEVICE FIRED CLIPS THAT WERE MORE NORMAL. HOWEVER, TWO OUT OF SIX CLIPS FED SIDEWAYS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT REPORTED. ADDITIONAL INFORMATION: THE SURGEON USES THESE DEVICES AS GRASPERS SOMETIMES TOO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA F4PL8W

    Patients

    Seq Age Sex Outcome Treatment
    1