BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONO STAN RF FORCEPS

    MDR report key: 2624060 · Received June 18, 2012

    Report

    Report Number
    2428235-2012-00009
    Event Type
    Injury
    Date Received
    June 18, 2012
    Date of Event
    May 14, 2012
    Report Date
    May 24, 2012
    Manufacturer
    ELLMAN INT'L INC.
    Product Code
    GEI
    PMA / PMN Number
    K71343
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULATION COATING AT THE DISTAL TIP OF THE DEVICE HAS BEEN TREATED WITH SOME IMPROPER CHEMICAL. IT IS NOT POSSIBLE TO DETERMINE THE EXACT NATURE OF THE CUSTOMER ABUSE, HOWEVER, THE COATING HAS BEEN SOFTENED UP AND REMAINS STICKY, LIKELY THROUGH CHEMICAL EXPOSURE SUCH AS (B)(4) FOR AN EXAMPLE. IN ANY CASE, IT IS UNLIKELY THAT THE SOFTENING OF THE COATING COULD HAVE HAPPENED DURING A PROCEDURE. AS SUCH, THE SOFTENED COATING WOULD HAVE BEEN EASILY DETECTABLE UPON INSPECTION PRIOR TO USE. ADDITIONALLY, THE INSULATION COATING HAS BEEN WORN AWAY AROUND THE SUCTION PORT AND THERE IS A "TEAR" IN THE COATING RUNNING PARALLEL TO THE SUCTION PORT ON THE SIDE OF THE DEVICE. THE WEAR PATTERN SUGGESTS THAT THE DEVICE HAS BEEN USED MULTIPLE TIMES AND, AS SUCH, DETERIORATED GRADUALLY. THIS BREAKDOWN OF THE PROTECTIVE INSULATION COATING COULD HAVE BEEN DETECTED WITH INSPECTION PRIOR TO THE SURGERY. ELLMAN'S "INSTRUCTIONS FOR USE" RECOMMENDS FORCEPS BE FREQUENTLY INSPECTED, BEFORE AND AFTER EACH USE, FOR DAMAGE AND BE DISCARDED AND REPLACED WHEN DAMAGE IS EVIDENT.

    Description of Event or Problem · 1

    MANUFACTURER'S DISTRIBUTOR REPORTED THAT DURING A BREAST PROCEDURE IN CLINIC IN (B)(6), THE PT RECEIVED A BURN TO BREAST NEAR MAMMARY FOLD WHEN THE INSULATION COATING OF THE FORCEPS MELTED. THE SIZE AND SEVERITY OF THE BURN WERE NOT PROVIDED. THE SURGEON CUT THE BURN AWAY. THERE WAS NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONO STAN RF FORCEPS GEI ELLMAN INT'L INC. MJ11

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention