BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOVIE MEDICAL

    MDR report key: 19950129 · Received August 9, 2024

    Report

    Report Number
    3007208013-2024-00038
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Report Date
    August 9, 2024
    Manufacturer
    BOVIE MEDICAL CORP.
    Product Code
    HQP
    UDI-DI
    00607151008956
    PMA / PMN Number
    K121441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS ABLE TO BE CONFIRMED BASED ON INFORMATION FROM THE END USER. CUSTOMER STATED THAT WHEN THE COVER CAP WAS RE-APPLIED AFTER USE, THE SWITCH WAS PUSHED UNDER THE LOCKING MECHANISM OF THE COVER CAP - HENCE LEAVING THE BUTTON PRESSED DOWN AND ACTIVATED. (SWITCH SHOULD BE ABOVE LOCKING MECHANISM OF CAUTERY TO PREVENT INADVERTENT ACTIVATIONS). ROOT CAUSE IS DETERMINED TO BE AN ISOLATED CASE OF USER ERROR. PER THE IFU - CUSTOMER SHOULD BE REMOVING THE TIP PRIOR TO PUTTING THE COVER CAP BACK ON - WHICH IN TURN BREAKS THE CIRCUIT AND PREVENT FURTHER ACTIVATIONS. 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.

    Description of Event or Problem · 0

    THE COMPLAINANT ALLEGES THE AA01X WAS ABLE TO BE ACTIVATED WHILE THE CAP WAS ENGAGED; "REPLACED CAP AS ONE IS SUPPOSED TO DO BUT WASN'T AWARE THAT IT CAN EASILY PRESS THE OPERATING BUTTON DOWN AND KEEP THE BOVIE ON AND HOT. NOTED BY NURSE SEVERAL MINUTES LATER AS IT WAS STARTING TO MELT ON THE TRAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2492253 BOVIE MEDICAL CAUTERY HQP BOVIE MEDICAL CORP. AA01X 0923Z 00607151008956

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown