BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM CLIP APPLIER

    MDR report key: 3842764 · Received June 2, 2014

    Report

    Report Number
    3005075853-2014-03690
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 12, 2014
    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). THE ANALYSIS RESULTS FOUND THAT THE EL5ML 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 4 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. FURTHERMORE, 1 MALFORMED CLIP AND 1 CLIP GAP WERE RECEIVED INSIDE THE SAMPLE BAG. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE RECEIVED MALFORMED CLIPS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE DEVICE IS RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION: DID LEGS OF CLIP AT SECOND FIRING CROSS OVER EACHOTHER OR WAS CLIP ONLY TEAR-DROP SHAPED WITH NO LEGS OF CLIP CROSSING? --- SOME CLIPS WERE TEARDROP SHAPED AND SOME CLIPS WERE SCISSORED. THIS EVENT OCCURRED FROM THE 2ND FIRING. WAS THERE ANY TORQUING OR TWISTING OF DEVICE WHEN FIRING? --- NO INFORMATION. WAS THERE RESISTANCE WHEN FIRING? --- NO INFORMATION. WAS CLIP FULLY ADVANCED INTO JAWS OF DEVICE BEFORE FIRING? --- NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY, A TEARDROP-SHAPED CLIP WAS FORMED OR SCISSORING OCCURRED AT THE 2ND FIRING. THE DEVICE DID NOT CLAMP SOMETHING HARD SUCH AS AN EXISTING CLIP. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICE WAS FIRED SEVERAL TIMES AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320870 LIGAMAX 5MM CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4E258

    Patients

    Seq Age Sex Outcome Treatment
    1