BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-Z CLEAN BALL 5IN

    MDR report key: 7770148 · Received August 9, 2018

    Report

    Report Number
    1721194-2018-00029
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    January 1, 2018
    Report Date
    July 25, 2018
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559100042
    PMA / PMN Number
    K862221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 9/7/2018. INVESTIGATION SUMMARY: RECEIVED ONE EACH USED SAMPLE. LOT NUMBER REPORTED TO BE 173902. NO PACKAGING WAS RECEIVED WITH THE PRODUCT. PRODUCT IS THE 5 INCH BALL ELECTRODE. CONFIRM A 4-5MM SPLIT IN THE INSULATION. IMMEDIATELY ADJACENT IS A SECONDARY SPLIT OF 2MM. THE DEVICE WAS POSSIBLY SLICED BUT UNABLE TO DETERMINE FOR CERTAIN. THERE ARE NO IMPRESSION MARKS OR SIGNATURE MARKS NOTED. THE INSULATION IS SPLIT FROM DISTAL TO PROXIMAL WHICH IS HIGHLY UNCOMMON (TO SPLIT IN THIS DIRECTION) ESPECIALLY CLOSE TO A LARGER BALL. INSULATION MAY HAVE BEEN "NICKED" BY SOMETHING AT SOME POINT, UNABLE TO DETERMINE WHERE, WHEN OR HOW THIS MAY HAVE OCCURRED. THERE IS HEAVY ESCHAR ON THE BALL PORTION. NO VISIBLE INITIATION MARKING SEEN UNDER MAGNIFICATION. EXACT CAUSE UNDETERMINED. A REVIEW OF THE DHR SHOWS THIS PRODUCT WAS ORIGINALLY MANUFACTURED TO SPECIFICATIONS AND THERE IS NO EVIDENCE OF DEVICE DEFECT OR MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PART OF THE BLUE COATING (NEAR TO THE BALL ELECTRODE) WAS BROKEN IN THE CASE OF COLPOSCOPY. X-RAY WAS TO BE PERFORMED FOR FINDING OUT THE BROKEN PART. PATIENT IMPACT UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607493 E-Z CLEAN BALL 5IN E-Z CLEAN BALL 5 INCH GEI MEGADYNE MEDICAL PRODUCTS, INC. 173902 10614559100042

    Patients

    Seq Age Sex Outcome Treatment
    1