BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-Z CLEAN MEGAFINE NDLE 2.5IN

    MDR report key: 9281824 · Received November 5, 2019

    Report

    Report Number
    1721194-2019-00134
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Date of Event
    September 9, 2019
    Report Date
    October 8, 2019
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559101414
    PMA / PMN Number
    K081791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAUDE REPORT # MW5089782. INVESTIGATION SUMMARY: 7 EACH 0118A LOT 193480 WAS RETURNED FOR EVALUATION. 6 UNOPENED DEVICES AND 1 EACH USED. NO MANUFACTURING DEFECTS WERE FOUND DURING INSPECTION OF THE 6 UNUSED DEVICES. THE USED DEVICE: THE BLACK MOST DISTAL INSULATION ON THE NEEDLE IS PEELED BACK AND HAS A MELTED APPEARANCE. ALSO, THE TIP OF THE MENTAL NEEDLE TIP IS MELTED. CHARRING ESCHAR RESIDUE IS VISIBLE AT THE BASE OF THE DAMAGED INSULATION. THE MOST LIKELY CAUSE OF THIS DAMAGE TO THE INSULATION IS DUE TO EXCESSIVE MECHANICAL LOAD/FORCES TO THE INSULATION. A BUILDUP OF TISSUE DEBRIS OR ESCHAR APPEARS TO HAVE COLLECTED UNDER THE INSULATION WITH EVIDENCE OF THIS TISSUE DEBRIS VISIBLE AT THE BASE OF THE SPLIT INSULATION. ALL THE PTFE COATING IS MISSING ON THE DISTAL END OF THE NEEDLE AND THE METAL TIP IS MELTED. THIS DAMAGE IS MOST LIKELY CAUSED BY OPERATING THE ELECTROSURGERY EQUIPMENT (GENERATOR) AT HIGH POWER SETTINGS WITH CONTINUAL ACTIVATION OF THE ELECTRODE FOR LONG PERIODS OR BY PLACING THE ELECTRODE TIP AGAINST ANOTHER INSTRUMENT CAUSING EXTREME HEAT WHICH RESULTS IN MELTING OF THE TIP. THE COMPLAINT IS CONFIRMED AS USE RELATED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BROW LIFT, THE DOCTOR WAS USING THE MEGADYNE E-Z TIP WITH A MEGADYNE MEGAPOWER GENERATOR FOR THIRTY MINUTES THEN THE TIP TURNED INTO A GLOWING BALL AND THE INSULATION BUBBLED UP ON IT, WHILE ACTIVATING. A SECOND LIKE E-Z TIP FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070912 E-Z CLEAN MEGAFINE NDLE 2.5IN E-Z CLEAN MEGAFINE NEEDLE 2.5 INCH GEI MEGADYNE MEDICAL PRODUCTS, INC. 193480 10614559101414

    Patients

    Seq Age Sex Outcome Treatment
    1