BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENCIL,ABC,BEND-A-BEAM,6" LONG

    MDR report key: 19125264 · Received April 17, 2024

    Report

    Report Number
    3007305485-2024-00059
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    January 20, 2024
    Report Date
    May 13, 2024
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    UDI-DI
    30653405002752
    PMA / PMN Number
    K961505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED THEREFORE, A DEVICE MALFUNCTION 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 THE FOLLOWING: THESE DEVICES SHOULD BE INSPECTED BEFORE USE. VISUALLY EXAMINE THE DEVICES FOR OBVIOUS PHYSICAL DAMAGE AND DO NOT USE IF FOUND: CRACKED, BROKEN OR OTHERWISE DISTORTED PLASTIC PARTS; BROKEN OR SIGNIFICANTLY BENT HANDLE, SHAFT OR CONNECTOR CONTACTS. 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. PROLONGED USE OF THE HANDPIECE CAUSES THE TIP TO BECOME VERY HOT AND THE TIP REMAINS HOT FOR A PERIOD AFTER USE. ALWAYS PLACE HANDPIECE IN A SAFE INSULATED LOCATION WHEN NOT IN USE, TO AVOID BURNS. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (B)(4) ON 26MAR24. 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, PENCIL, ABC, BEND-A-BEAM, 6" LONG, DEVICE. IT WAS STATED THAT THE DEVICE WAS BEING USED DURING A LIVER TRANSPLANT ON (B)(6) 2024. THE REPORT STATED, ¿ABC BEND-A-BEAM HANDPIECE WAS USED FOR COAGULATION DURING SURGERY AND WHEN NOT IN USE IT WAS PLACED INTO UTILITY POCKET, AFTER PLACEMENT INTO PLASTIC UTILITY POCKET THE HANDPIECE BEGAN TO SMOKE AND BURNED A HOLE THROUGH THE UTILITY POCKET. THE TEAM NOTED THE PLASTIC TIP OF THE HANDPIECE WAS ALSO MELTED AT THIS TIME. WHEN THE SMOKE WAS NOTED, THE HANDPIECE WAS IMMEDIATELY PLACED IN SALINE. HANDPIECE WAS DISPOSED OF.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT #(B)(4) ON 26MAR24. 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, PENCIL, ABC, BEND-A-BEAM, 6" LONG, DEVICE. IT WAS STATED THAT THE DEVICE WAS BEING USED DURING A LIVER TRANSPLANT ON (B)(6) 2024. THE REPORT STATED, "ABC BEND-A-BEAM HANDPIECE WAS USED FOR COAGULATION DURING SURGERY AND WHEN NOT IN USE IT WAS PLACED INTO UTILITY POCKET, AFTER PLACEMENT INTO PLASTIC UTILITY POCKET THE HANDPIECE BEGAN TO SMOKE AND BURNED A HOLE THROUGH THE UTILITY POCKET. THE TEAM NOTED THE PLASTIC TIP OF THE HANDPIECE WAS ALSO MELTED AT THIS TIME. WHEN THE SMOKE WAS NOTED, THE HANDPIECE WAS IMMEDIATELY PLACED IN SALINE. HANDPIECE WAS DISPOSED OF".THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. 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
    1892738 PENCIL,ABC,BEND-A-BEAM,6" LONG ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY 202310054 30653405002752

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male