BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2241967 · Received September 9, 2011

    Report

    Report Number
    3005075853-2011-03724
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 16, 2011
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? UNK. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? UNK. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? UNK. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? UNK. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? UNK. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? YES. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION; THE JAWS WERE NOTED TO BE IN GOOD CONDITION. IN AN ATTEMPT TO REPLICATE THE EVENT REPORTED THE DEVICE WAS FUNCTIONALLY EVALUATED. UPON FIRING OF THE DEVICE, THE REMAINING CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT APPLICATION OF THE EXCESSIVE/INCORRECT TORQUE CAUSE A TEMPORALLY MISALIGNMENT OF THE JAWS. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN THE DEVICE JAWS WERE PLACED ON TISSUE PRIOR TO FIRING THE JAWS OVER LAPPED. THEY WERE NOT ALIGNED. THEY TOOK THE DEVICE OUT OF THE PATIENT, ATTEMPTED TO FIRE AND IT FIRED FINE. THE JAWS WERE ALIGNED. WHEN THEY PLACED IT ON TISSUE THE JAWS WOULD NOT BE ALIGNED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H4425A

    Patients

    Seq Age Sex Outcome Treatment
    1