BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOVIE MEDICAL

    MDR report key: 19996802 · Received August 15, 2024

    Report

    Report Number
    3007208013-2024-00039
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Report Date
    September 13, 2024
    Manufacturer
    BOVIE MEDICAL CORP.
    Product Code
    HQP
    UDI-DI
    00607151011215
    PMA / PMN Number
    K121441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TWO NEW/UNUSED PRODUCTS WERE RETURNED FROM THE CUSTOMERS BOX FOR TESTING. THE DEVICES WERE HEATED PER IFU INSTRUCTIONS OF 2 SECONDS ON WITH 6 SECONDS OFF. AS AN EXTREME CASE: THE DEVICE WAS HEATED FOR 2 SECONDS AND THEN TOUCHED AGAINST A HARD METAL INSTRUMENT. (PRODUCT IS INTENDED FOR PINPOINT COAGULATION). THE DEVICE REMAINED HOT FOR THE DURATION OF THE TOUCH, DID NOT BEND WHEN TOUCHING THE DEVICE WHILE HEATED, AND THEN WAS RELEASED AND COOLED APPROPRIATELY. COMPLAINT COULD NOT BE CONFIRMED AT THIS TIME. THIS IS BELIEVED TO BE AN INCIDENT OF ACCIDENTAL USER DAMAGE TO THE DEVICE, EITHER THROUGH EXTENDED ACTIVATIONS OR EXCESSIVE FORCE BEING APPLIED TO THE FRAGILE TIP. IF ADDITIONAL INFORMATION IS OBTAINED THAT IS PERTINENT TO THE INVESTIGATION OR PROVIDES ADDITIONAL DETAILS A FOLLOW-UP REPORT WILL BE PROVIDED. UNTIL SUCH TIME, THIS CAN BE SEEN AS THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    AWAITING ADDITIONAL INFORMATION AND/OR RETURN OF THE REPORTED DEVICE TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 0

    THE COMPLAINANT ALLEGES, "THE METAL TIP ON THE END OF THE CAUTERY HIGH TEMP TOOL IS VERY FLIMSY AND HAS BEEN BREAKING OFF (OR BURNING ITSELF OUT) DURING VASECTOMY PROCEDURES. HE HAS HAD TO USE 2 OR 3 ITEMS PER PROCEDURE, IN THE PAST ONE ITEM HAS BEEN USED."

    Description of Event or Problem · 0

    THE COMPLAINANT ALLEGES, "THE METAL TIP ON THE END OF THE CAUTERY HIGH TEMP TOOL IS VERY FLIMSY AND HAS BEEN BREAKING OFF (OR BURNING ITSELF OUT) DURING VASECTOMY PROCEDURES. HE HAS HAD TO USE 2 OR 3 ITEMS PER PROCEDURE, IN THE PAST ONE ITEM HAS BEEN USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152909 BOVIE MEDICAL CAUTERY HQP BOVIE MEDICAL CORP. AA21 1023Z 00607151011215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown