BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR 2000

    MDR report key: 21650842 · Received March 20, 2025

    Report

    Report Number
    3007305485-2025-00050
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    February 5, 2025
    Report Date
    April 9, 2025
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEITHER THE DEVICE NOR PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. A DEVICE HISTORY REVIEW (DHR) REVIEW FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS REPORTED EVENT. THE SERVICE HISTORY WAS REVIEWED, AND NO PRIOR DATA WAS FOUND. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 11 COMPLAINTS, REGARDING 11 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 TO MINIMIZE THE POSSIBILITY OF SHOCKING DURING MONOTERMINAL APPLICATIONS: DO NOT LET YOUR PATIENT COME IN CONTACT WITH ANY GROUNDED METAL OBJECTS. POSITION THE ELECTRODE ON OR CLOSE TO THE PATIENT BEFORE ACTIVATING THE OUTPUT. FOR PROCEDURES USING THE DISPERSIVE PLATE, DO NOT ALLOW THE PATIENT TO BREAK CONTACT WITH THE DISPERSIVE PLATE WHEN THE UNIT IS ACTIVATED. IF THE PHYSICIAN OR NURSE MUST TOUCH THE PATIENT, PLACE HAND ON THE PATIENT BEFORE ACTIVATING THE HYFRECATOR® 2000. DO NOT BREAK CONTACT DURING ACTIVATION. TO LESSEN THE POSSIBILITY OF A SHOCK, WEAR GLOVES AT ALL TIMES AND CONTINUE TO AVOID CONTACT WITH GROUNDED METAL OBJECTS. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, 7-900-115, HYFRECATOR 2000, 115V/50-60HZ, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THE SURGEON RECEIVED A SHOCK WHEN USING THE UNIT, THE OUTLETS WERE CHECKED AND NO ISSUE WITH THEM.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR THE USER. THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT THE USE OF AN ALTERNATE DEVICE. 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, 7-900-115, HYFRECATOR 2000, 115V/50-60HZ, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THE SURGEON RECEIVED A SHOCK WHEN USING THE UNIT, THE OUTLETS WERE CHECKED AND NO ISSUE WITH THEM.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR THE USER. THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT THE USE OF AN ALTERNATE DEVICE. 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
    1592654 HYFRECATOR 2000 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY 23513165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown