BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1912716 · Received December 2, 2010

    Report

    Report Number
    3005075853-2010-06808
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 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
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EMPTY THE ANALYSIS RESULTS OF THE FOUND THAT IT WAS RECEIVED EMPTY AND LOCKED OUT; THEREFORE NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE EVENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INGUINAL HERNIA PROCEDURE, IT IS ALLEGED THAT THE CLIP APPLIER MISFIRED THE FIRST CLIP. WHEN THE APPLIER WAS PLACED ON A SMALL EPIGASTRIC VESSEL IT APPEARED NOT FIRED AND THEN THE JAWS GOT STUCK ON THE VESSEL WHEN THE APPLIER WAS TAKEN AWAY. THE CLIP APPLIER WAS USED AGAIN A FEW TIMES IN THE CASE WHERE THE CLIPS WERE FORMED BUT THE JAWS WERE STICKING AFTER CLIPS FIRED. THIS DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    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 G4TT36

    Patients

    Seq Age Sex Outcome Treatment
    1