BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TONSIL PACK

    MDR report key: 14776779 · Received June 22, 2022

    Report

    Report Number
    1423395-2022-00024
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    June 7, 2022
    Report Date
    June 22, 2022
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    OGR
    UDI-DI
    10195327073602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE FACILITY THAT DURING THE BEGINNING OF A TONSILLECTOMY /ADENOIDECTOMY, THE SURGEON STATED THAT WHEN HE ACTIVATED THE BOVIE HE WITNESSED A VISIBLE FLAME FOR A SPLIT SECOND AND REMOVED THE DEVICE FROM SERVICE. THE SURGICAL TEAM CHANGED THE BOVIE PENCIL, TIP, CAUTERY PAD AND ELECTROCAUTERY MACHINE BEFORE CARRYING ON WITH THE PROCEDURE. THERE WAS REPORTEDLY NO VISIBLE INJURY TO THE PATIENT AND NO IMPACT ON THE PROCEDURE BEING PERFORMED, THE PROCEDURE WAS ABLE TO BE COMPLETED. IT WAS REPORTED THAT THE DEVICE WAS SET TO 30 CUT/30 COAG. NO ADDITIONAL INFORMATION IS AVAILABLE. A SAMPLE WAS RECEIVED FOR EVALUATION. THE CUSTOMER RETURNED ONE CAUTERY PENCIL AND CAUTERY TIP AS A SAMPLE FOR OUR INVESTIGATION. THE REST OF THE PACK WAS NOT RECEIVED AT THIS TIME. THE END USER REPORTEDLY NOTED A FLAME COMING FROM THE BOVIE TIP. THE SAMPLE WAS OBSERVED WITH DARK CHAR ON THE END OF THE CAUTERY TIP AND THE CLEAR INSULATION APPEARS SLIGHTLY DEFORMED, A DEFINITIVE ROOT CAUSE WAS NOT ABLE TO BE ESTABLISHED. NO ADDITIONAL INFORMATION IS AVAILABLE. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE BEGINNING OF A TONSILLECTOMY/ADENOIDECTOMY, THE SURGEON NOTICED A SMALL FLAME AT THE TIP OF THE BOVIE WHEN HE ACTIVATED THE DEVICE. NO INJURY WAS NOTED TO THE PATIENT, THE DEVICE WAS IMMEDIATELY REMOVED FROM SERVICE AND REPLACED WITH A NEW BOVIE PENCIL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958978 TONSIL PACK TONSIL PACK OGR MEDLINE INDUSTRIES LP DYNJ908452 10195327073602

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Female Other