BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3123985 · Received May 15, 2013

    Report

    Report Number
    2134070-2013-00106
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 8, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE EVAL SHOWED THAT THE DEVICE WAS RETURNED WITH THE JAWS CLEARLY MISALIGNED. UPON EVAL, THE DEVICE WAS FUNCTION TESTED IN AN ATTEMPT TO REPLICATE THE EVENT. WHEN THE TRIGGER WAS ACTUATED, THE FIRST CLIP DID NOT SIT SECURELY IN BOTH SIDES OF THE JAWS, BUT SAT SECURELY IN THE LEFT SIDE OF THE JAWS WHILE THE RIGHT SIDE OF THE CLIP ONLY TOUCHED THE JAWS AT ONE POINT. WHEN THIS FIRST CLIP WAS FIRED, THE CLIP WAS PINCHED ONLY ON THE ENDS IN A TEAR DROP SHAPE. THE TWO OTHER REMAINING CLIPS NEVER CAUGHT IN THE MISALIGNED JAWS, BUT FELL OUT OF THE JAWS COMPLETELY UNFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED. AS EACH DEVICE IS INSPECTED AND TEST FIRED PRIOR TO BEING RELEASED, NO CONCLUSION COULD BE MADE AS TO WHAT MAY HAVE CAUSED THE EVENT. THE INSTRUCTIONS FOR USE STATE "NEVER FIRE THE INSTRUMENT OVER ANOTHER CLIP OR INSTRUMENT. FIRING THE INSTRUMENT IN THIS MANNER MAY DISTORT OR YIELD THE INSTRUMENT JAWS." ETHICON ENDO-SURGERY, LLC IS CONDUCTING A VOLUNTARY RECALL OF CERTAIN MODEL ER320 DEVICES. STERILMED INITIATED A PASS THROUGH RECALL ON (B)(4) 2013 OF ALL ITS REPROCESSED ER320 MODELS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLIPS DID NOT CROSS WHEN FIRED, REMAINED OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. THIS REPORT IS BEING FILED FOR THE FINDINGS UPON EVAL. ADD'L INFO WAS REQUESTED, BUT NO ADD'L INFO WAS PROVIDED. A F/U REPORT WILL BE SENT IF ADD'L INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214523 NA NMJ STERILMED, INC. ETHER320 1604960

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR