BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-Z CLEAN BLADE MOD 2.5IN

    MDR report key: 9769893 · Received February 28, 2020

    Report

    Report Number
    1721194-2020-00024
    Event Type
    Injury
    Date Received
    February 28, 2020
    Date of Event
    November 28, 2019
    Report Date
    February 3, 2020
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559100110
    PMA / PMN Number
    K081791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: (B)(6) 2020. INVESTIGATION SUMMARY ONE EACH 0012M LOT NUMBER 192558 WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION FOUND A BURN HOLE AND MELTED INSULATION MATERIAL AT THE PROXIMAL END OF THE BLUE INSULATION. THE MOST LIKELY CAUSE IS TISSUE AND FLUID BUILDUP WHICH ALLOWED OR FORCED THE MATERIALS INTO THE NOSE OF THE PENCIL WHERE THE ELECTRODE IS INSERTED. SUCH CONDITIONS FAVOR INITIATION OF AN ELECTRICAL DISCHARGE WHICH CAN RESULT IN THERMAL DAMAGE TO SURROUNDING TISSUE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT IS THE PRODUCT CODE ON THIS COMPLAINT? THE TIPS ARE 0012M. WHAT IS THE LOT/BATCH NUMBER ON THE DEVICE? LOT NUMBER 192558. WHAT IS THE SEVERITY OF THE BURN? FIRST DEGREE BURNS ARE MINOR BURNS ON THE FIRST LAYER OF SKIN. SECOND DEGREE BURNS HAVE TWO TYPES: SUPERFICIAL PARTIAL-THICKNESS BURNS INJURE THE FIRST AND SECOND LAYERS OF SKIN. DEEP PARTIAL-THICKNESS BURNS INJURE DEEPER SKIN LAYERS. THIRD DEGREE BURNS INJURE ALL THE SKIN LAYERS AND TISSUE UNDER THE SKIN. WHAT MEDICAL INTERVENTION WAS USED TO TREAT THE BURN? (SUCH AS SALVE OR STITCHES). ARE THERE ANY ANTICIPATED LONG-TERM EFFECTS FROM THE BURN OR INJURY? THE TREATMENT WAS EXCISION OF THE BURNED SKIN EDGE AT THE TIME OF SURGERY. THE REMAINING BURNS HEALED WELL WITH SIMPLE DRESSINGS. NO LONG TERM EFFECTS ANTICIPATED. THE TIP WAS MEGADYNE 0012M, THE PENCIL WAS COVIDIEN AND THE DIATHERMY MACHINE WAS MARTIN. DIATHERMY REDUCED TO BE SET AT 30/30 PURE CUT/SPRAY SAME THING HAPPENED, THIS TIME THE DAMAGE TO THE MEGADYNE SHAFT WAS FURTHER UP. INVESTIGATION SUMMARY ONE EACH 0012M LOT NUMBER 192558 WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION FOUND A BURN HOLE AT THE PROXIMAL END OF THE BLUE INSULATION. THE COMPLAINT IS CONFIRMED AS USE RELATED, HOWEVER WITHOUT EXAMINATION OF THE PENCIL INVOLVED IN THE EVENT THE EXACT USER RELATED SCENARIO CANNOT BE DETERMINED. 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 AN UNKNOWN PROCEDURE, THERE WAS A SURGICAL BURN TO PATIENTS USING MEGADYNE INSULATED TIPS IN CONJUNCTION WITH COVIDIEN HANDPIECE. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230841 E-Z CLEAN BLADE MOD 2.5IN E-Z CLEAN BLADE MODIFIED 2.5 INCH GEI MEGADYNE MEDICAL PRODUCTS, INC. 0012M 10614559100110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other