BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAUTERY HIGH TEMP LOOP TIP

    MDR report key: 20232212 · Received September 16, 2024

    Report

    Report Number
    3007208013-2024-00048
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 16, 2024
    Manufacturer
    BOVIE MEDICAL CORP.
    Product Code
    HQP
    PMA / PMN Number
    K121441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER WAS PROVIDED FOR THE INVESTIGATION. AFTER OBTAINING ADDITIONAL INFORMATION FROM THE REPORTER, THE ROOT CAUSE IS DETERMINED TO BE ACCIDENTAL USER ERROR. THE CAUTERY TIP WAS VERY HOT AFTER BEING USED, AND IT WAS PLACED IN CONTACT WITH A GAUZE SPONGE WITHOUT THE COVER CAP ON THE CAUTERY TIP. PER THE IFU, IT IS STATED "CAUTERY TIP WILL REMAIN HOT IMMEDIATELY AFTER DEACTIVATION AND MAY CAUSE INADVERTENT BURNS TO USER OR PATIENT. ALWAYS RETAIN THE COVER CAP AND REPLACE IT ON THE CAUTERY WHEN NOT IN USE." THIS SHOULD BE CONSIDERED THE FINAL REPORT. HOWEVER, IF ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGES "THE PHYSICIAN SAYS THE UNIT SEEMED TO HAVE BEEN RUNNING MUCH HOTTER THAN IT SHOULD HAVE. THE DISPOSABLE CAUTERY UNIT STARTED SMOLDERING WHEN IT TOUCHED A GAUZE SPONGE. IT PRODUCED A SMALL FLAME, BUT IT WAS EXTINGUISHED, AND DID NOT CAUSE ANY INJURIES." THIS IS LOGGED IN OUR COMPLAINT SYSTEM AS COMP (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2506613 CAUTERY HIGH TEMP LOOP TIP CAUTERY LOOP TIP HQP BOVIE MEDICAL CORP. AA03 0923Z

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown