BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-Z CLEAN L-WIRE LAP 45CM

    MDR report key: 9676659 · Received February 6, 2020

    Report

    Report Number
    1721194-2020-00019
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 16, 2020
    Report Date
    January 17, 2020
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559102640
    PMA / PMN Number
    K913281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INVESTIGATION SUMMARY: 1 EACH 0100L LOT 192290 WAS RETURN. A SLIT IN THE INSULATION WAS OBSERVED WITH EXCESSIVE CHARRED ESCHAR EXTENDING THE FROM THE TIP TO THE BOTTOM OF THE SLIT DAMAGE. THE COATING WAS COMPLETELY MISSING INDICATING THE TIP HAS BEEN USED FOR LONG DURATION WITH EXCESSIVE HEAT AND CONTINUED TO BE USED AFTER THE INSULATION WAS SPLIT AND DAMAGED. IT IS KNOWN THAT THE TIP BECOMES HOT UPON ACTIVATION AND IF ESCHAR TISSUE BUILDUP IS PRESENT IT COULD BECOME A GLOWING EMBER AND REVIEW OF THE PHOTOS OF THE DEVICE INDICATES THE TIP WAS VERY HOT AT THE TIME OF THE EVENT. THE COMPLAINT IS CONFIRMED AS USER DAMAGE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED.,THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 2/6/2020. BATCH #UNK. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 4/13/2020. ADDITIONAL INFORMATION: TWO PHOTOS WERE PROVIDED. A SLIT IN THE INSULATION WAS OBSERVED WITH EXCESSIVE CHARRED ESCHAR EXTENDING FROM THE TIP TO THE BOTTOM OF THE SLIT DAMAGE. IT WAS ALSO EVIDENT FROM THE PHOTOS THAT THE COATING WAS COMPLETELY MISSING INDICATING THE TIP HAS BEEN USED FOR LONG DURATIONS WITH EXCESSIVE HEAT AND CONTINUED TO BE USED AFTER THE INSULATION WAS SPLIT AND DAMAGED. IT IS KNOWN THAT THE TIP BECOMES HOT UPON ACTIVATION AND IF ESCHAR TISSUE BUILDUP IS PRESENT IT COULD BECOME A GLOWING EMBER AND REVIEW OF THE PHOTOS OF THE DEVICE INDICATES THE TIP WAS VERY HOT AT THE TIME OF THE EVENT. THE COMPLAINT IS CONFIRMED AS USER DAMAGE. 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 LAPARATOMY VAGINAL HYSTERECTOMY, THE TEFLON COATING AROUND THE ELECTRODE EXPLODED. A SECOND LIKE DEVICE WAS TRIED AND IT DID THE SAME THING. A FORCE TRIAD GENERATOR WAS BEING USED AT THAT TIME. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143018 E-Z CLEAN L-WIRE LAP 45CM E-Z CLEAN WIRE L-WIRE LAP 45CM GEI MEGADYNE MEDICAL PRODUCTS, INC. 0100L 10614559102640

    Patients

    Seq Age Sex Outcome Treatment
    1