BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3880145 · Received June 18, 2014

    Report

    Report Number
    3005075853-2014-04094
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: EJECTED CLIP, YIELDED JAW THE ER320. DEVICE WAS RETURNED FOR ANALYSIS AND UPON INSPECTION THE JAWS WERE FOUND TO BE IN A YIELDED CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE REMAINING 12 CLIPS WERE EJECTED AND THEN, IT LOCKED OUT AS INTENDED. POSSIBLE CAUSES FOR THE CONDITION FOUND MAY BE IF THE DEVICE IS CLOSED OVER AN EXISTING HARD OBJECT OR CLIP PLACING STRESS ON THE JAWS CAUSING THEM TO DISTORT OR YIELD AND NOT RETURN TO THEIR ORIGINAL DIMENSIONS/POSITION OR EXCESSIVE APPLICATION OF TORQUE TO THE JAWS WHEN POSITIONING THE DEVICE ON A VESSEL. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE CONDITION OF THE JAWS MAY LEAD DROPPING/EJECTED CLIPS. DUE TO THE CONDITION OF THE RETURNED DEVICE IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED 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 JAMMED AND WOULD NOT FIRE ON FIRST TRY. A NEW DEVICE WAS USED WHICH FUNCTIONED APPROPRIATELY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357959 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4DM98

    Patients

    Seq Age Sex Outcome Treatment
    1