BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1853068 · Received October 5, 2010

    Report

    Report Number
    3005075853-2010-05686
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH ONE PEAR SHAPED INSIDE THE JAWS. IN AN ATTEMPT TO REPLICATE THE EVENT REPORTED, THE DEVICE WAS TESTED FOR FUNCTIONALITY. DUE TO THE ANTI BACKUP FEATURE BEING NON-FUNCTIONAL, TWO UNFORMED CLIPS WERE FED. POSSIBLE CAUSES FOR THIS CONDITION MAY BE ATTEMPTING TO SQUEEZE THE DEVICE TRIGGER WHEN IT HAS NOT FULLY RETURNED OR STOPPING THE FIRING SEQUENCE AND PULLING THE TRIGGER OPEN. THE REMAINING CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. FINALLY, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS VISIBLE AT THE 14TH FIRING SEQUENCE; THUS, IT WAS NOT COMPLETELY VISIBLE. THESE FINDINGS ARE NOT RELATED WITH THE INCIDENT REPORTED. THE JAWS WERE NOTED TO BE IN GOOD CONDITION; NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. 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 BEFORE A LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY PROCEDURE, IT WAS FOUND BEFORE USE ON THE PATIENT THAT THE JAW HAD CLOSED WHEN A WHITE CAP WAS REMOVED. 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
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1