BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEGADYNE

    MDR report key: 2665496 · Received July 18, 2012

    Report

    Report Number
    1721194-2012-00005
    Event Type
    Other
    Date Received
    July 18, 2012
    Report Date
    July 18, 2012
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS RELATED TO A REPORT PREVIOUSLY FILED BY MEDLINE INDUSTRIES, INC # (B)(4). MEGADYNE EVAL - UPON RECEIPT OF THE REPORT, A REVIEW OF THE LOT HISTORY RECORDS WAS CONDUCTED AND REVEALED THIS DEVICE WAS MFG ACCORDING TO DMR SPECS AND WE CAN FIND NO EVIDENCE TO SUGGEST A DEVICE DEFECT OR MALFUNCTION WHICH MIGHT HAVE CONTRIBUTED TO A FAILURE OF THIS NATURE. A REVIEW OF THE PRODUCT HISTORY REVEALS THIS ELECTRODE TO BE A RELIABLE COMPONENT OF ELECTROSURGERY. VISUAL INSPECTION OF THE RETURNED SAMPLE REVEALED EVIDENCE OF ARCING AT THE PROXIMAL END OF THE INSULATION INDICATING THE PRESENCE OF AN ALTERNATE CURRENT PATH WHERE THE TIP WAS INSERTED INTO THE PENCIL. THE IFU PROVIDES ADEQUATE INSTRUCTION ON THE PROPER USE OF THE DEVICE INCLUDING THE NEED TO INSURE THE ELECTRODE IS FULLY INSERTED INTO THE PENCIL. WE ARE UNABLE TO ESTABLISH A CAUSAL RELATIONSHIP BETWEEN THE PROPER INSTALLATION AND USE OF THE DEVICE AND THE REPORTED EVENT. WE CONSIDER THIS MATTER TO BE CLOSED.

    Description of Event or Problem · 1

    PT WAS BURNED ON HER SKIN WHEN THE MEDLINE PENCIL ARCED FROM THE TIP INSERT COLLAR OF THE PENCIL TO THE END OF THE MEGADYNE 0012AM TIP. DR (B)(6) REMARKED THAT THE MEGADYNE TIP WAS ROTATING IN THE PENCIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGADYNE COATED BLADE ELECTRODE GEI MEGADYNE MEDICAL PRODUCTS, INC. 20568

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention PACK| MEDLINE (B)(4) CAUTERY DEVICE WITHIN SURGICAL