BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-Z CLEAN L-WIRE LAP 33CM

    MDR report key: 7777067 · Received August 13, 2018

    Report

    Report Number
    1721194-2018-00030
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    July 25, 2018
    Report Date
    July 27, 2018
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559100677
    PMA / PMN Number
    K913281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 9/18/2018 . INVESTIGATION SUMMARY: RECEIVED ONE EACH OF THE 0100, LOT NUMBER 181795. THE INSULATION WAS DETACHED. THE L HOOK WAS COVERED IN BLACK ESCHAR. THE DISTAL END OF THE INSULATION WAS COMPLETELY TORN AWAY APPROXIMATELY 5/8 OF AN INCH FROM WHERE IT SHOULD END, THERE WAS A SPLIT LINE THAT THE TEAR FOLLOWS. THERE ARE IMPRESSION MARKS MOST LIKELY FROM A RIGID OBJECT OR INSTRUMENT/DEVICE. THERE WAS SHAVING OR SLICING, HARD TO TELL DUE TO THE DEGREE OF DISFIGURING OF THE INSULATION. THIS COULD BE THE RESULT OF EXCESSIVE MECHANICAL LOADING DURING USE (CONTACT WITH ANOTHER RIGID OBJECT). POWER SETTINGS DON'T APPEAR TO HAVE BEEN EXCESSIVE, THE INSULATION WAS COMPROMISED PRIOR TO THE SPLITTING AS EVIDENCED BY THE IMPRESSION MARKS. 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 LAPAROSCOPIC CHOLECYSTECTOMY THE INSULATION DETACHED FROM THE DISTAL END OF THE TIP AROUND THE WIRE ELECTRODE. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620785 E-Z CLEAN L-WIRE LAP 33CM E-Z CLEAN WIRE L-WIRE LAP 33 CM GEI MEGADYNE MEDICAL PRODUCTS, INC. 10614559100677

    Patients

    Seq Age Sex Outcome Treatment
    1