BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 4200315 · Received October 24, 2014

    Report

    Report Number
    3005075853-2014-07351
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ER320 DEVICE WAS RETURNED FOR ANALYSIS WITH A CLIP IN THE JAWS; THE CLIP WAS REMOVED IN ORDER TO INSPECT THE JAWS AND THEY WERE FOUND TO BE YIELDED AND MISALIGNED. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT THE DEVICE WAS FUNCTIONALLY EVALUATED. UPON TESTING, THE DEVICE WAS CYCLED AND TEN SCISSORED CLIPS WERE FORMED DUE TO THE MISALIGNED CONDITION OF THE JAWS; FINALLY THE INSTRUMENT LOCKED OUT AS INTENDED. POSSIBLE CAUSES FOR THE FOUND CONDITION OF THE YIELDED JAWS 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, TWO DEVICES WERE NOT FORMING CLIPS PROPERLY AND WERE DELIVERING SCISSORED CLIPS. THIS OCCURRED ON THE FIRST FIRING WITH BOTH DEVICES. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF A CHOLANGIOGRAM WAS USED DURING THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679868 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1