BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTEF COATED LAPAROSCOPIC ELECTRODE

    MDR report key: 5145165 · Received October 13, 2015

    Report

    Report Number
    5145165
    Event Type
    Malfunction
    Date Received
    October 13, 2015
    Date of Event
    May 15, 2015
    Report Date
    September 21, 2015
    Manufacturer
    PROGRESSIVE MEDICAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A LAPAROSCOPIC GASTRIC SLEEVE AND CHOLECYSTECTOMY. THE TEFLON COATED L-HOOK ELECTRODE MELTED WHEN ENGAGED IN THE PATIENT. THE SURGEON REMOVED THE INSTRUMENT AND INSPECTED IT. THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS RETURNED TO THE VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677256 PTEF COATED LAPAROSCOPIC ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI PROGRESSIVE MEDICAL, INC. P0020 1407401

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR