BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1933203 · Received December 20, 2010

    Report

    Report Number
    3005075853-2010-07262
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 22, 2011
    Report Date
    November 30, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT ONE DEVICE WAS RECEIVED WITH TWO MALFORMED CLIPS AND ONE PEAR SHAPED CLIP. THE JAWS WERE CLEARED AND WHEN THE REMAINING CLIPS WERE FIRED, THE CLIPS DID NOT FULLY ADVANCE INTO THE JAW CAUSING PEAR SHAPED CLIPS. THE DEVICE WAS NOTED TO HAVE THE TIP OF THE ADVANCER BENT. ONE POSSIBLE CAUSE FOR THE CONDITION FOUND IS ACTUATING THE DEVICE WHEN THE JAWS ARE NOT CLEAR OF THE TROCAR. ACTUATING THE DEVICE WITH THE JAWS CLOSED MAY BEND THE ADVANCER. SUBSEQUENT ACTUATIONS OR MANUAL OPENING OF THE DEVICE MAY BEND THE ADVANCER TIP BACK TOWARD ITS ORIGINAL POSITION AND BREAK THE ADVANCER TIP. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS DID NOT FORM. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK G4TV9E

    Patients

    Seq Age Sex Outcome Treatment
    1