BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Disposable Electrode Serie

    MDR report key: 8324938 · Received February 11, 2019

    Report

    Report Number
    8324938
    Event Type
    Malfunction
    Date Received
    February 11, 2019
    Date of Event
    September 11, 2018
    Report Date
    January 8, 2019
    Manufacturer
    PROGRESSIVE MEDICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY, THE LAPAROSCOPIC HOOK CAUTERY BOVIE SPARKED. THE HOOK WAS REMOVED FROM THE OPERATING FIELD AND REPLACED WITH A NEW ONE. THE MALFUNCTIONING HOOK WAS COLLECTED AND PLACED IN ITS ORIGINAL PACKAGING, AND SUBMITTED TO MATERIALS MANAGEMENT. THE BOVIE MACHINE WAS SENT TO BIOMED FOR EVALUATION. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120603 Disposable Electrode Serie ELECTROSURGICAL, CUTTING, COAGULATION GEI PROGRESSIVE MEDICAL, INC. P0020 1710053

    Patients

    Seq Age Sex Outcome Treatment
    1