BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3161598 · Received June 11, 2013

    Report

    Report Number
    3005075853-2013-02917
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. MULTIPLE REQUEST FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED. WHAT VESSEL WAS THE DEVICE FIRED ON? BLEEDING CAME FROM THE CYSTIC ARTERY. WERE ANY UNEXPECTED NOISES HEARD? THERE WERE NO ANOMALIES NOTICED DURING FIRING OF THE DEVICE. HOW MUCH BLOOD DID THE PATIENT LOST? COULD BE STOPPED BY A LIGATURE. WAS A TRANSFUSION REQUIRED? THERE WAS NO TRANSFUSION REQUIRED. WHAT IS THE PATIENT¿S CURRENT STATUS? PATIENT IS FINE. NO FURTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT DEVICES (A, B AND D) WERE RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, EACH DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICES WERE CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. IN ORDER TO CONFIRM THE CLIPS WERE WITHIN MANUFACTURING SPECIFICATIONS, THE CLIPS WERE EVALUATED USING A TOOL THAT IS DESIGNED TO DETERMINE PROPER FORMATION. DURING ANALYSIS THE JAWS OPEN AND CLOSE AS INTENDED. IN ADDITION, EACH DEVICE LOCKED OUT AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORDS WERE REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOUND THAT DEVICE (C) WAS RECEIVED IN GOOD VISUAL CONDITION WITH THE JAWS PROPERLY ALIGNED. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY, LOCKED OUT AND THE ORANGE INDICATOR WAS FOUND UNDERTRAVELED. THE DEVICE IS DESIGNED TO LOCK OUT WHEN ALL THE CLIPS HAVE BEEN FIRED. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE INCIDENT REPORTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. DEVICE C ADDITIONAL INFORMATION: BATCH # J93441, EXPIRATION DATE: 11/2017, MANUFACTURING DATE: 12/2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THERE WERE BLEEDINGS AND THE CLIPS PERFORATED THE TISSUE. NO FURTHER INFORMATION IS AVAILABLE. PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262395 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4CV62

    Patients

    Seq Age Sex Outcome Treatment
    1