BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-Z CLN L-WR LAP SPLIT STEM 33CM

    MDR report key: 7856650 · Received September 7, 2018

    Report

    Report Number
    1721194-2018-00034
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Date of Event
    June 1, 2018
    Report Date
    June 6, 2018
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559100677
    PMA / PMN Number
    K913281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. INVESTIGATION SUMMARY: ONE 0100S DEVICE WAS RECEIVED. THERE WAS ALSO PACKAGING FOR LOT NUMBER 180822. IT IS UNCERTAIN IF THIS DEVICE WAS FROM THAT LOT NUMBER. THE DEVICE HAD SPLIT INSULATION. THE DEVICE HAD BLACKENED LAYER OF ESCHAR ON THE OUTSIDE OF THE COATING WHICH MAY HAVE BEEN RELATED TO ARCING, 2-3 MM SPLIT IN THE INSULATION. THERE IS AN IMPRESSION MARK AT THE LEADING EDGE OF THE SPLIT. UNABLE TO DETERMINE THE INITIAL CAUSE. SPLITTING DOESN'T LOOK EXCESSIVE BUT IS USUALLY CAUSED BY A COMBINATION OF HIGHER POWER ACTIVATION AND MECHANICAL LOADING (PHYSICAL PRESSURE TO INSULATION) OF THE INSULATION. UNABLE TO DETERMINE CAUSE WITH ANY CERTAINTY. IT IS LIKELY USE RELATED. A DHR REVIEW WAS PERFORMED, AND THERE IS NO EVIDENCE OF DEVICE DEFECT OR MALFUNCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GYN PROCEDURE, A LARGE FLASH OR ARCING WAS NOTED DURING ACTIVATION WITHIN THE ABDOMINAL CAVITY. UPON INSPECTION, A TEAR OR WEAKNESS IN THE INSULATION WAS NOTED AND THE DEVICE WAS REPLACED. THERE WAS A 3-5 MIN DELAY, NO PATIENT COMPLICATIONS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695362 E-Z CLN L-WR LAP SPLIT STEM 33CM E-Z CLEAN WIRE L-WIRE LAP SPLIT STEM 33 CM GEI MEGADYNE MEDICAL PRODUCTS, INC. 180822. 10614559100677

    Patients

    Seq Age Sex Outcome Treatment
    1