BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1898980 · Received November 15, 2010

    Report

    Report Number
    3005075853-2010-06521
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: THE APPLICATOR DO NOT STAPLE SINCE IT HAVE TO OF FACT OBSTRUCT IN THE CYSTIC ARTERY ON HAVING TRIED TO REMOVE IT AND TO THE MOMENT TO TEAR EXTRACT IN THE ARTERY CAUSING A LITTLE BLEEDING. THE DR. DID SOME SHOTS OUTSIDE THE PATIENT IN THE SURGICAL FIELD AND TRY TO SEE OUT THE OTHER CLIPS WHERE A IS CLOSED AND THE OTHER SHOULD NOT CLOSE AS .

    Additional Manufacturer Narrative · 1

    (B)(4). ANTIBACKUP FAILURE, RATCHET. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE EVENT REPORTED, THE DEVICE WAS TESTED FOR FUNCTIONALITY. IT WAS FIRED AND DUE THE ANTIBACKUP FEATURE WAS NON-FUNCTIONAL TWO PARTIALLY FORMED CLIPS WERE FED. THE DEVICE LOCKED OUT AS INTENDED. IN ORDER TO EVALUATE THE CONDITION OF THE DEVICE'S INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED AND THE RATCHET PAWL WAS FOUND TO BE WORN OUT THUS; LEADING THE ANTIBACKUP FAILURE. 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. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE REPORTED EVENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THERE WAS NO CLIPPING. THE APPLICATOR DOES NOT CLIP TO OBSTRUCT THE CYSTIC ARTERY AND WHEN TRYING TO REMOVE IT, IT TORE THE ARTERY CAUSING A LITTLE BLEEDING. THE DR. DID SOME FIRING OUTSIDE THE PATIENT IN THE SURGICAL FIELD AND TRIED TO SEE IF THE OTHER CLIPS WHERE CLOSED AND THE OTHERS DID NOT CLOSE. SURGERY WAS PROLONGED FIFTEEN MINUTES. ANOTHER LIKE 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. G4TD6J

    Patients

    Seq Age Sex Outcome Treatment
    1