BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3250842 · Received July 29, 2013

    Report

    Report Number
    3005075853-2013-03775
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 21, 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). WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? ---AS THE SURGEON FELT A DIFFICULTY BEFORE THE 1ST FIRING, THE DEVICE DID NOT USE ON THE PATIENT. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? ---THE DEVICE DID NOT USE ON THE PATIENT. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? ---NO. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? ---THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WERE ANY UNEXPECTED NOISES HEARD? ---THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? ---THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? ---THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS 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. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED. PLEASE NOTE THAT PRIOR TO LOADING A CLIP IN THE JAWS, ENSURE THAT THE DEMARCATION BETWEEN THE JAWS AND THE DEVICE SHAFT IS PAST THE END OF THE TROCAR CANNULA. ADDITIONALLY, EXCESSIVELY APPLYING A SIDE LOAD TO THE JAWS, CAUSING THEM TO PARTIALLY COLLAPSE COULD RESULT IN A CLIP MALFORMATION. THE DEVICE JAWS SHOULD BE FULLY OPEN AND PARALLEL UPON INITIATING THE FIRING OF THE DEVICE. 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, THE CLIP WAS NOT FED INTO THE JAWS PROPERLY AT THE 1ST FIRING. TWO CLIPS SEEMED TO BE FED AT THE SAME TIME. THE DEVICE WAS NOT USED FOR THE PATIENT. NO CLIPS FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352700 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1