BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX

    MDR report key: 3568363 · Received January 10, 2014

    Report

    Report Number
    3005075853-2014-00229
    Event Type
    Malfunction
    Date Received
    January 10, 2014
    Date of Event
    November 14, 2013
    Report Date
    November 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 Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANTI-BACKUP FAILURE. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION WITH A CLIP PARTIALLY FED INTO THE JAWS; THE CLIP WAS REMOVED IN ORDER TO PERFORM FUNCTIONAL TESTING. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, ONE UNFORMED CLIP WAS FED DUE TO THE ANTIBACKUP FEATURE WAS NON-FUNCTIONAL AND THEN, IT LOCKED OUT AS INTENDED. IN ORDER TO EVALUATE THE DEVICE¿S INTERNAL COMPONENTS THE INSTRUMENT WAS DISASSEMBLED. UPON DISASSEMBLING OF THE DEVICE, THE RATCHET PAWL WAS FOUND OUT OF POSITION CAUSING THE ANTIBACKUP FAILURE. DURING ANALYSIS, NO DOUBLE FEED ISSUES WERE NOTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. A BATCH RECORD REVIEW WAS PERFORMED AND THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, TWO CLIPS WERE FED INTO THE JAWS AT A TIME FROM THE 4TH FIRING. THE CLIP WAS FED INTO THE JAW PROPERLY TILL THE 3RD FIRING. THE DEVICE WAS FIRED OUTSIDE THE PATIENT SEVERAL TIMES TO CHECK ITS FUNCTION, BUT THE SAME EVENT OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AT THE 1ST AND THE 2ND FIRING, THE DEVICE APPROACHED TO THE BLOOD VESSEL AFTER THE CLIP WAS FED INTO THE JAWS. AT THE 3RD FIRING, THE DEVICE APPROACHED TO THE BLOOD VESSEL AND THEN THE CLIP WAS FED INTO THE JAWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19700 LIGAMAX CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1