BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1873266 · Received October 18, 2010

    Report

    Report Number
    3005075853-2010-05920
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 24, 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 OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH JAWS IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS; ONE PEAR SHAPED CLIP WAS RELEASED. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE REMAINING CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. IT SHOULD BE NOTED THAT AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE OPENING ISSUES. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT COMPLETELY VISIBLE. THIS FINDING IS NOT RELATED TO THE INCIDENT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RADICAL PROSTATECTOMY PROCEDURE, THE JAW WOULD NO LONGER OPEN. THE JAW DID NOT CLAMP THE TISSUE. ANOTHER 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 CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1