BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABC® BEND-A-BEAM®

    MDR report key: 21255765 · Received January 28, 2025

    Report

    Report Number
    3007305485-2025-00011
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    January 8, 2025
    Report Date
    February 7, 2025
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    UDI-DI
    30653405002752
    PMA / PMN Number
    K961505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF RETURNED USED DEVICE FOUND THAT THE TIP OF THE DEVICE WAS DISCOLORED. FUNCTIONAL EXAMINATION OF RETURNED USED DEVICE 134006 FOUND THAT THE DEVICE WORKED AS INTENDED. FUNCTIONAL TESTING WAS COMPLETED WITH SYSTEM 7550. ROOT CAUSE CANNOT BE DETERMINED, HOWEVER, BASED UPON IFU; A POSSIBLE CAUSE OF THIS EVENT COULD BE PROLONGED USE. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: PROLONGED USE OF THE HANDPIECE CAUSES THE TIP TO BECOME VERY HOT AND THE TIP REMAINS HOT FOR A PERIOD AFTER USE. DO NOT ALLOW THE TIP TO COME IN CONTACT WITH THE PATIENT OR OTHERS AFTER ACTIVATION TO AVOID BURNS. ALWAYS PLACE HANDPIECE IN A SAFE INSULATED LOCATION WHEN NOT IN USE, TO AVOID BURNS. DO NOT TEST THE CONMED ABC® ELECTROSURGICAL GENERATOR BY SPARKING THE ACTIVE ELECTRODE TO THE PATIENT PLATE OR OTHER OBJECTS. USE LOWEST POSSIBLE POWER SETTING ON THE CONMED ABC® ELECTROSURGICAL GENERATOR CAPABLE OF ACHIEVING THE DESIRED SURGICAL EFFECT. USE SHORTEST EFFECTIVE ABC® ACTIVATION TIME NECESSARY. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS BEEN RETURNED TO CONMED; HOWEVER, THE INVESTIGATION OF THE DEVICE HAS NOT BEEN COMPLETED. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE 134006, HANDPIECE HANDCONTROL MALLEABLE HANDPIECE, WAS BEING USED ON (B)(6) 2025 AND ¿WE HAD ARGON BEAM COAGULATOR HANDPIECE CATCH ON FIRE, DR. HAD JUST BEGUN THE LIVER TRANSPLANT AND AS HE STARTED TO USE THE ABC, THE TIP OF THE HANDPIECE CAUGHT FIRE. OR DIRECTOR, WAS CALLED TO THE ROOM AND THE PHYSICIAN DESCRIBED IT AS IF IT LOOKED LIKE A CANDLE WITH AN ACTIVE FLAME. SOME OF THE PLASTIC DID MELT AND DRIP ON THE SURGICAL RESIDENT, HOWEVER, THE PATIENT WAS UN- HARMED.¿. PER FURTHER ASSESSMENT IT WAS FOUND THE RESIDENT WAS NOT HARMED. NO FRAGMENTS FELL INTO THE SURGICAL SITE. THERE WAS NO IMPACT OR INJURY FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE 134006, HANDPIECE HANDCONTROL MALLEABLE HANDPIECE, WAS BEING USED ON (B)(6) 2025 AND ¿WE HAD ARGON BEAM COAGULATOR HANDPIECE CATCH ON FIRE, DR. HAD JUST BEGUN THE LIVER TRANSPLANT AND AS HE STARTED TO USE THE ABC, THE TIP OF THE HANDPIECE CAUGHT FIRE. OR DIRECTOR, WAS CALLED TO THE ROOM AND THE PHYSICIAN DESCRIBED IT AS IF IT LOOKED LIKE A CANDLE WITH AN ACTIVE FLAME. SOME OF THE PLASTIC DID MELT AND DRIP ON THE SURGICAL RESIDENT, HOWEVER, THE PATIENT WAS UN- HARMED.¿. PER FURTHER ASSESSMENT IT WAS FOUND THE RESIDENT WAS NOT HARMED. NO FRAGMENTS FELL INTO THE SURGICAL SITE. THERE WAS NO IMPACT OR INJURY FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440964 ABC® BEND-A-BEAM® ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY 202407314 30653405002752

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female