BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABC BEND-A-BEAM

    MDR report key: 19907079 · Received August 5, 2024

    Report

    Report Number
    3007305485-2024-00114
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 9, 2024
    Report Date
    September 18, 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
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    RECEIVED ONE 134006 IN OPENED ORIGINAL PACKAGE. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION, WHICH VERIFIED THE REPORTED EVENT. PERFORMED A FUNCTIONAL INSPECTION USING THE ESU SYSTEM 7550 (C8406), THE DEVICE FUNCTIONED AS INTENDED. ROOT CAUSE CANNOT BE DETERMINED, HOWEVER, BASED UPON THE IFU; A POSSIBLE CAUSE OF THIS EVENT COULD BE THAT BEFORE USE THE DEVICE WAS NOT EXAMINED FOR OBVIOUS PHYSICAL DAMAGE. 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. A TWO-YEAR LOT HISTORY REVIEW SHOWS A TOTAL OF (B)(4) DEVICE FOR THIS LOT NUMBER AND FAILURE MODE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF FOUR REPORTS, REGARDING FOUR DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: THE USER IS ADVISED THAT 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. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 134006, PENCIL,ABC,BEND-A-BEAM,6" LONG DEVICE WAS BEING USED DURING A HEPATECTOMY OPEN PROCEDURE ON (B)(6) 2024, AND ¿AFTER 2 OR 3 ARGON FIRING, THE SURGEON NOTICE THAT THE CERAMIC TIP WAS MISSING. FORTUNATELY ENOUGH, THEY FIND IT IN THE PATIENT BODY ON THE LIVER. THEY TOOK ANOTHER, 134006 TO DO THE CASE¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE AND A DELAY OF 5 MINUTES. FOLLOW-UP ASSESSMENT FOUND THAT ALL FRAGMENTS AND COMPONENTS WERE RETRIEVED FROM THE PATIENT BY HAND. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 134006, PENCIL, ABC, BEND-A-BEAM, 6" LONG DEVICE WAS BEING USED DURING A HEPATECTOMY OPEN PROCEDURE ON (B)(6) 2024, AND ¿AFTER 2 OR 3 ARGON FIRING, THE SURGEON NOTICE THAT THE CERAMIC TIP WAS MISSING. FORTUNATELY ENOUGH, THEY FIND IT IN THE PATIENT BODY ON THE LIVER. THEY TOOK ANOTHER, 134006 TO DO THE CASE¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE AND A DELAY OF 5 MINUTES. FOLLOW-UP ASSESSMENT FOUND THAT ALL FRAGMENTS AND COMPONENTS WERE RETRIEVED FROM THE PATIENT BY HAND. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252182 ABC BEND-A-BEAM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY 202401234 30653405002752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown