BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM

    MDR report key: 3895098 · Received June 25, 2014

    Report

    Report Number
    3005075853-2014-04398
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 6, 2014
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). YIELDED JAW. THE ANALYSIS RESULTS OF THE EL5ML DEVICE FOUND THAT IT WAS RECEIVED WITH A CONFORMING CLIP LATCHED IN JAWS AND 1 PEAR SHAPED CLIP JAMMED UNDERNEATH THE ADVANCER. THIS CONDITION PREVENTED THE DEVICE FROM PROPER FEEDING OF THE CLIPS. THE JAMMED CLIPS WERE REMOVED FROM THE DEVICE AND IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT; THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE REMAINING 11 CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED. PLEASE NOTE AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. 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 ASSISTED DISTAL GASTRECTOMY, JAMMING OCCURRED AND CLIP WAS NOT FED INTO THE JAWS WHEN THE DEVICE INTENDED TO BE FIRED ON THE BLOOD VESSEL. IT WAS UNKNOWN WHICH FIRING OF THE DEVICE THIS EVENT OCCURRED ON. THERE WAS NO TORQUING OR TWISTING OF THE DEVICE PRESENT. THE DEVICE WAS NOT FIRED ON SOMETHING HARD SUCH AS AN EXISTING CLIP. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371864 LIGAMAX 5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1