BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 14246684 · Received April 28, 2022

    Report

    Report Number
    3007220801-2022-00012
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    March 4, 2022
    Report Date
    April 28, 2022
    Manufacturer
    BOVIE MEDICAL CORP
    Product Code
    GEI
    UDI-DI
    05088538001459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS PURCHASED ON AN UNKNOWN ORDER NUMBER AS ONLY THE MFG DATE WAS KNOWN FOR THE PRODUCT AND NOT THE LOT NUMBER OF THE DEVICE. CUSTOMER RESPONDED WITH THE FOLLOWING INFORMATION: PRODUCT WAS NOT INSPECTED PRIOR TO SURGERY. NO OXYGEN SOURCE WAS PRESENT NEAR THE ACTIVATION SITE. CUSTOMER WAS NOT SURE WHAT MATERIAL LED TO THE SPARK, HOWEVER THEY BELIEVE THIS WAS MOST LIKELY TISSUE CONTACT. CUSTOMER PREPPED SIT WITH POVIDONE-IODINE. CAUTERY USE (ACTIVATION CYCLE AND RESTING TIME) IS UNKNOWN. FLAME OCCURRED ON INITIAL ACTIVATION OF THE DEVICE. CUSTOMER CONFIRMED THERE WAS NO DELAY IN PROCEDURE AND THAT A NEW DEVICE WAS USED AND ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY. PRODUCT IS NOT AVAILABLE FOR RETURN. CUSTOMER DID NOT TAKE PICTURES OF THE DEVICE IN QUESTION. COMPLAINT COULD NOT BE CONFIRMED WITHOUT FURTHER INFORMATION FROM THE END USER. ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. HOWEVER, WE BELIEVE THIS MAY BE AN INCIDENT OF WHERE THE CAUTERY DEVICE CAME INTO CONTACT WITH A FLAMMABLE SUBSTANCE. THE COMPLAINT RATE FOR THIS OCCURRENCE IS (B)(4). BASED ON THE ABOVE INFORMATION, NO FURTHER ACTIONS REQUIRED. THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR THE NEED FOR CORRECTIVE ACTIONS, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THAT DURING A SUBUNGUAL HEMATOMA PROCEDURE, A FLAME OCCURRED WHEN USING THE CAUTERY DEVICE. THE CUSTOMER WAS ABLE TO EXTINGUISH THE FLAME WITH NO DAMAGE TO THE PATIENT'S FINGER OR NAIL. THE CUSTOMER WAS ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER CUATERY WITHOUT DELAYING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889456 CARDINAL HEALTH CAUTERY GEI BOVIE MEDICAL CORP UNKNOWN 05088538001459

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown