BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 2971674 · Received February 21, 2013

    Report

    Report Number
    3005075853-2013-00778
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 31, 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS UNEXPECTED RESISTANCE IN GRASPING THE TRIGGER AT THE 1ST FIRING WHEN THE DEVICE WAS USED ON THE BLOOD VESSEL AND THE JAWS COULD NOT BE OPENED. THE DEVICE WAS RELEASED MANUALLY. AFTER THAT, WHEN THE DEVICE WAS FIRED AT THE 2ND FIRING, THE JAWS COULD NOT BE OPENED AS WELL. THE DEVICE WAS RELEASED MANUALLY. ALTHOUGH THE JAWS CLAMPED THE TARGET TISSUE AT THE INCIDENT, NO DAMAGE WAS CONFIRMED AFTER THE DEVICE WAS RELEASED. WHEN THE DEVICE WAS FIRED OUTSIDE THE PATIENT, IT WAS FIRED PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE TARGET TISSUE WAS NORMAL. THERE WAS NO TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING. THE DEVICE WAS NOT FIRED ACROSS SOMETHING HARD SUCH AS A CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76899 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1