BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3082540 · Received April 29, 2013

    Report

    Report Number
    3005075853-2013-02018
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 4, 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). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND LOCKED OUT. THE INSTRUMENT IS DESIGNED TO LOCK OUT AFTER ALL THE CLIPS HAVE BEEN FIRED; THEREFORE A POTENTIAL CAUSE OF THE CUSTOMER REPORTED EXPERIENCE IS THE FIRING OF ALL OF THE CLIPS AND THE INSTRUMENT "WILL NOT FIRE" (ACTIVATION OF THE LOCK OUT MECHANISM). THE INSTRUMENT HAS AN ORANGE INDICATOR THAT APPEARS ON THE TOP OF THE HANDLE AS A REFERENCE FOR THE USER AS TO THE QUANTITY OF CLIPS REMAINING. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN ILEAL CONDUIT PROCEDURE, THE TRIGGER HAD A DIFFICULTY IN BEING RETURNED TO HOME POSITION DURING USE ON THE ILEUM. THE DEVICE WAS FIRED PROPERLY. NO DAMAGES ON THE TARGET TISSUE WERE CONFIRMED. 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
    183800 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4CJ7H

    Patients

    Seq Age Sex Outcome Treatment
    1