BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3894148 · Received June 25, 2014

    Report

    Report Number
    3005075853-2014-04316
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 2, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = YIELDED JAW, EJECTED CLIP. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: TO CLARIFY: AT WHAT FIRING DID THE ISSUE OCCUR? DON'T KNOW DID THE CLIP FEED INTO THE JAWS SIDEWAYS? DON'T KNOW BUT WAS TOLD "CLIP WAS LOOSE" DID THE CLIP DROP FROM THE DEVICE? WAS TOLD "CLIP FELL OUT OF JAW ONCE DEVICE WAS PLACED THROUGH TROCAR AND WHEN ATTEMPTING TO POSITION ON TISSUE" IF SO HOW AS THE CLIP RETRIEVED FROM THE PATIENT? GRASPER 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 1 CLIP WAS 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 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 DEVICE HISTORY RECORDS WERE 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 A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, PER THE STAFF IN THE ROOM "CLIP FELL OFF IN PATIENT BEFORE CLIPPING, DOES NOT SEEM PROPERLY ALIGNED." PER THE DOCTOR THIS WAS THE SECOND INCIDENT. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE; DIFFERENT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372048 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4D846

    Patients

    Seq Age Sex Outcome Treatment
    1