BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2181774 · Received July 27, 2011

    Report

    Report Number
    3005075853-2011-03043
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 16, 2011
    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). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE TIP OF THE ADVANCER SLID TOWARD TISSUE STOP CAUSING THAT THE JAWS REMAINED IN THE CLOSED. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED; A PEAR SHAPED CLIP WAS RELEASED. CONFORMING CLIPS WERE FED DURING THE NEXT TWO FIRING SEQUENCES AND THEN, A SHORT FEED OCCURRED CAUSING A CLIP WITH GAP. HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR UNDER TRAVELED. THE ORANGE VISUAL INDICATOR IS A MECHANISM IN THE HANDLE OF THE DEVICE THAT SHOWS "ORANGE" WHEN THE DEVICE HAS EXHAUSTED ITS CLIPS. POTENTIAL CAUSES OF AN UNDER TRAVELED ORANGE VISUAL INDICATOR MAY BE: THE INDICATOR WHEEL IN THE HANDLE OF THE DEVICE MAY BECOME TEMPORARILY DISENGAGED DUE TO A DIMENSIONAL SHIFT OF MULTIPLE COMPONENTS INVOLVED ALLOWING TWO COMPONENTS TO SLIP PAST ONE ANOTHER; HIGHER THAN NORMAL FRICTION OF THE MECHANISM MAY CAUSE ONE OR MORE PARTS TO TEMPORARILY STICK. PLEASE NOTE THE UNDER-TRAVEL OF THE INDICATOR WHEEL IS NOT RELATED TO THE REPORTED EVENT. 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 A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS USED FOR THE CYSTIC DUCT. THE DEVICE COULD BE FIRED PROPERLY AT THE FIRST FIRING WHEN THE DEVICE FUNCTION WAS CHECKED OUTSIDE OF THE PATIENT BY A NURSE. ALTHOUGH THE DEVICE COULD BE FIRED PROPERLY AT THE 2ND FIRING, THE TRIGGER BECAME NOT TO BE GRASPED AND THE CLIP DID NOT COME OUT AT THE 3RD FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H43638

    Patients

    Seq Age Sex Outcome Treatment
    1