BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-Z CLEAN ELECTRODES

    MDR report key: 7098975 · Received December 8, 2017

    Report

    Report Number
    7098975
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    November 27, 2017
    Report Date
    November 30, 2017
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY A SMALL BLACK PLASTIC PIECE OF LAPAROSCOPIC BOVIE HOOK (MEGADYNE) BROKE OFF INSIDE OF PATIENT. DOCTOR RETRIEVED IT WITH THE LAPAROSCOPIC SUCTION/IRRIGATOR. TURNED DEVICE IN, WITH ORIGINAL PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878996 E-Z CLEAN ELECTRODES ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEGADYNE MEDICAL PRODUCTS, INC. 0100S 174771

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NO| NO OTHER THERAPIES