BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOVIE MEDICAL

    MDR report key: 1830244 · Received September 2, 2010

    Report

    Report Number
    3007593903-2010-00005
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K014201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION CONFIRMED THE BROKEN WIRE ON THE ES16R ELECTRODE. WE ATTEMPTED TO DUPLICATE THE REPORTED NONCONFORMANCE USING AN ES16R ELECTRODE USING THE SAME GENERATOR AND SETTINGS USED BY THE END USER (13 WATTS SETTING IN FULGURATION MODE USING AN A950 GENERATOR). UNDER SIMULATION, THE LOOP WIRE BROKE AFTER 2 ACTIVATIONS. FULGURATION MODE IS NOT INTENDED FOR USE WITH AN ELECTRODE. PER THE CURRENT LOOP ELECTRODE INSTRUCTION FOR USE (MC-18051), THE RECOMMENDED SETTINGS FOR LOOP ELECTRODES SPECIFY A MAXIMUM SETTING OF 55 WATTS IN PURE CUT OR BLEND MODE. THE USER ATTEMPTED TO USE THE DEVICE IN FULGURATION MODE.

    Description of Event or Problem · 1

    THE WIRE BROKE DURING FIRST USE OF A REUSABLE LLETZ LOOP ELECTRODE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOVIE MEDICAL ELECTROSURGICAL ELECTRODE GEI BOVIE MEDICAL CORPORATION ES16R 2009-02-02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK