BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABC® BEND-A-BEAM®

    MDR report key: 24375663 · Received February 18, 2026

    Report

    Report Number
    3007305485-2026-00018
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    December 11, 2025
    Report Date
    March 10, 2026
    Manufacturer
    CONMED
    Product Code
    GEI
    UDI-DI
    30653405002752
    PMA / PMN Number
    K961505
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. 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.

    Additional Manufacturer Narrative · 0

    NEITHER THE DEVICE NOR PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. 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 THAT 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. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED BY THE FINDING OF MAUDE REPORT NUMBER: MW5181199 ON 4FEB2026. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST A 134006, HANDPIECE HANDCONTROL MALLEABLE HANDPIECE,6" (15.2 CM), DEVICE. THE DATE OF THE PROCEDURE WAS ON (B)(6) 2025. THE REPORT STATES, ¿DURING PROCEDURE, STAFF DETECTED A NOTICEABLE PLASTIC ODOR. UPON INSPECTION, THE SURGEON OBSERVED THAT THE DEVICE (CONMED BEND-A-BEAM) HANDPIECE HAD PARTIALLY MELTED. THE PROCEDURE WAS PAUSED, AND THE DEVICE WAS REMOVED. THERE WERE NO BURNS OR VISIBLE INJURY TO THE PATIENT OR SURROUNDING TISSUE.¿ NO FURTHER ASSESSMENT CAN BE MADE BY CONMED AS THE REPORTER HAS REMAINED ANONYMOUS. THE REPORT STATED THAT INTERVENTION WAS REQUIRED AND THE EVENT TYPE IS LISTED AS ¿SERIOUS INJURY¿, EVEN THOUGH THE EVENT DESCRIPTION CLAIMS NO INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY LISTED IN THE MAUDE REPORT.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED BY THE FINDING OF MAUDE REPORT NUMBER MW5181199 ON 4FEB26. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST A 134006, HANDPIECE HANDCONTROL MALLEABLE HANDPIECE, 6" (15.2 CM), DEVICE. THE DATE OF THE PROCEDURE WAS (B)(6) 2025. THE REPORT STATES, "DURING PROCEDURE, STAFF DETECTED A NOTICEABLE PLASTIC ODOR. UPON INSPECTION, THE SURGEON OBSERVED THAT THE DEVICE (CONMED BEND-A-BEAM) HANDPIECE HAD PARTIALLY MELTED. THE PROCEDURE WAS PAUSED, AND THE DEVICE WAS REMOVED. THERE WERE NO BURNS OR VISIBLE INJURY TO THE PATIENT OR SURROUNDING TISSUE." NO FURTHER ASSESSMENT CAN BE MADE BY CONMED AS THE REPORTER HAS REMAINED ANONYMOUS. THE REPORT STATED THAT INTERVENTION WAS REQUIRED AND THE EVENT TYPE IS LISTED AS "SERIOUS INJURY", EVEN THOUGH THE EVENT DESCRIPTION CLAIMS NO INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY LISTED IN THE MAUDE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449478 ABC® BEND-A-BEAM® ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED 202503184 30653405002752

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention| O