BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3250176 · Received July 26, 2013

    Report

    Report Number
    3005075853-2013-03766
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    July 12, 2013
    Report Date
    July 17, 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). ADDITIONAL INFORMATION: PLEASE CLARIFY: THE INDICATOR WAS SHOWN---THE ORANGE INDICATOR SHOWED FROM THE 1ST FIRING. WAS THE DEVICE EMPTY? ---NO. DID THE INDICATOR SHOW AT THE END OF THE DEVICE SHAFT BUT THERE WERE STILL CLIPS IN THE DEVICE? ---YES. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? --- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? ---NO. WERE ANY UNEXPECTED NOISES HEARD? ---YES, THE CLOSING SOUND OF THE JAW WAS BIGGER THAN USUAL. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? --- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. THE ORANGE INDICATOR WAS NOTED TO BE 2/3 ADVANCED WHICH DENOTES 1 CLIP WAS REMAINING IN THE DEVICE. 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 CLIP AS INTENDED. IN ORDER TO CONFIRM THE CLIP WAS WITHIN MANUFACTURING SPECIFICATIONS, THE CLIP WAS EVALUATED USING A TOOL THAT IS DESIGNED TO DETERMINE PROPER FORMATION. DURING ANALYSIS THE JAWS OPEN AND CLOSE AS INTENDED. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. 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 SIGMOIDECTOMY PROCEDURE, THE JAWS CLOSED AND WOULD NOT OPEN AT THE 1ST FIRING AND THE CLIP WAS NOT FED INTO THE JAWS. THE JAWS WERE OPENED BY RETURNING THE TRIGGER TO THE HOME POSITION BY HAND. ALTHOUGH THIS INCIDENT OCCURRED AT THE 1ST FIRING, THE INDICATOR WAS SHOWN. 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
    350049 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1