BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7627571 · Received June 21, 2018

    Report

    Report Number
    1721194-2018-00021
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Date of Event
    June 1, 2018
    Report Date
    June 7, 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). THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 9/7/2018. INVESTIGATION SUMMARY: ONE 0100S DEVICE WAS RECEIVED. THERE WAS ALSO PACKAGING FOR LOT NUMBER 180822. UNCERTAIN IF THIS DEVICE WAS FROM THAT LOT NUMBER. THE DEVICE HAD SPLIT INSULATION. THE DEVICE SHOWS EXTREME EVIDENCE OF RIGID DEVICE CONTACT WITH THE DISTAL END OF THE DEVICE. EVIDENCED BY THE INSULATION BEING SHAVED, PEELED AND SPLIT. INSULATION DAMAGE IS POSSIBLY FROM CANNULA CONTACT DURING DEVICE REMOVAL. MULTIPLE BREECHES IN INSULATION ALL GO FROM PROXIMAL TOWARD DISTAL IN DIRECTION OF DAMAGE WHICH INDICATES DAMAGE OCCURRING WHEN DEVICE IS BEING WITHDRAWN. NO SIGNS OF ARCING. USER DAMAGE UNABLE TO DETERMINE IF THE DEVICE HAD ARCED. 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, 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
    468719 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. 10614559100677

    Patients

    Seq Age Sex Outcome Treatment
    1