BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19200840 · Received April 29, 2024

    Report

    Report Number
    3007305485-2024-00064
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 3, 2024
    Report Date
    June 11, 2024
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    PMA / PMN Number
    K961505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    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. H3 OTHER TEXT : DEVICE NOT YET RECEIVED.

    Additional Manufacturer Narrative · 0

    RECEIVED ONE 134006 IN UNORIGINAL PACKAGE. LOT NUMBER WAS NOT VERIFIED. PERFORMED A VISUAL INSPECTION, NO ABNORMALITIES OR DEFECTS WERE CONFIRMED. PERFORMED A FUNCTIONAL INSPECTION USING THE ESU SYSTEM 7550 (C8406), THE COMPLAINT WAS NOT CONFIRMED. THE DEVICE FUNCTIONED AS INTENDED. A TWO-YEAR LOT HISTORY REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A DEVICE HISTORY REVIEW (DHR) CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF (B)(4) COMPLAINTS, REGARDING (B)(4) 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 NOT TO IMMERSE OR SATURATE HAND CONTROL PENCIL OR CORD IN FLUID. DO NOT PULL ON OR STRETCH THE HANDPIECE CORD. 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 FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE 134006, PENCIL,ABC,BEND-A-BEAM,6" LONG WAS BEING USED ON (B)(6) 2024 DURING A KP TRANSPLANT PROCEDURE WHEN IT WAS REPORTED HANDPIECE CAUGHT ON FIRE WHILE IN USE - FIRE WAS CONTAINED TO THE HANDPIECE (NO INJURY NOTED TO PT) HANDPIECE DOUSED WITH WATER.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE. IT WAS ALSO REPORTED THAT "THE DEVICE DID NOT CAUSE PATIENT HARM. I AM UNAWARE OF PATIENT'S STATE." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE 134006, PENCIL,ABC,BEND-A-BEAM,6" LONG WAS BEING USED ON (B)(6) 2024 DURING A KP TRANSPLANT PROCEDURE WHEN IT WAS REPORTED HANDPIECE CAUGHT ON FIRE WHILE IN USE - FIRE WAS CONTAINED TO THE HANDPIECE (NO INJURY NOTED TO PT) HANDPIECE DOUSED WITH WATER¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE. IT WAS ALSO REPORTED THAT "THE DEVICE DID NOT CAUSE PATIENT HARM. I AM UNAWARE OF PATIENT'S STATE." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000894 PENCIL,ABC,BEND-A-BEAM,6" LONG ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown