BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1250800 · Received December 2, 2008

    Report

    Report Number
    3005075853-2008-03371
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 30, 2008
    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

    ADVANCER. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE EL5ML INSTRUMENT WAS RETURNED WITH THE JAWS CLOSED AND THE TRIGGER PARTIALLY CYCLED. THE TRIGGER AND JAWS WERE RETURNED TO THE OPEN POSITION AND THE ADVANCER BYPASSED FIVE CLIPS DURING THE FIRST FIVE FIRING SEQUENCES THEREFORE PRODUCING PEAR SHAPED CLIPS; HOWEVER, THE REMAINING TEN CLIPS WERE FED AND FORMED AS INTENDED. NO JAMMING ISSUES WERE NOTED DURING TESTING. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE FOUND FAILURE MODE. WE HAVE DOCUMENTED THE CIRCUMSTANCE AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL GASTRECTOMY PROCEDURE, JAMMING OCCURRED DURING THE FIRST FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT. ONE DEVICE WILL BE RETURNING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1