BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3972679 · Received August 1, 2014

    Report

    Report Number
    3005075853-2014-05384
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 28, 2014
    Report Date
    June 30, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THE CLIPS ADVANCING INTO THE JAWS EVERY TIME THE TRIGGER WAS ACTIVATED? YES. DID THE CLIPS DEPLOY FROM THE JAWS OF THE DEVICE EVERY TIME THE TRIGGER WAS ACTIVATED? NO.

    Additional Manufacturer Narrative · 1

    (B)(4) = JAWS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WERE THE CLIPS ADVANCING INTO THE JAWS EVERY TIME THE TRIGGER WAS ACTIVATED? DID TH CLIPS DEPLOYING FROM THE JAWS OF THE DEVICE EVERY TIME THE TRIGGER WAS ACTIVATED? THE ER320 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION WITH A CLIP IN THE JAWS. THE CLIP WAS USED FOR PERFORMING THE MANUAL TRANSVERSE CLIP RETENTION TEST; THE ROTATION KNOB WAS DISASSEMBLED FROM THE DEVICE IN ORDER TO PERFORM THE TEST AND THE INSTRUMENT PASSED IT SUCCESSFULLY. THE JAWS WERE MEASURED AND THEY WERE FOUND TO BE YIELDED AND MISALIGNED. IN ORDER TO PERFORM FUNCTIONAL TESTING, THE DEVICE WAS CYCLED AND IT FED AND FORMED NINE SCISSORED CLIPS DUE TO THE MISALIGNED CONDITION OF THE JAWS; THE INSTRUMENT LOCKED OUT AS INTENDED. IT IS KNOWN FROM THE HISTORY OF THE INSTRUMENT THAT AN INCORRECT/EXCESSIVE APPLICATION OF TORQUE TO THE JAWS DURING INSTRUMENT USE CREATES A MISALIGNMENT OF THE TIPS. IN ADDITION AS PER THE INSTRUCTIONS FOR USE ¿DO NOT EXCESSIVELY TWIST OR TORQUE THE INSTRUMENT JAWS WHEN POSITIONING THE INSTRUMENT ON A VESSEL AND FIRING. EXCESSIVE TWISTING OR TORQUING MAY RESULT IN CLIP MALFORMATION¿. 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 THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN THE PRODUCT WAS MISFIRING THE CLIPS. NO OTHER INFORMATION AVAILABLE AT THIS POINT. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450349 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1