BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYFRECATOR 2000

    MDR report key: 23277276 · Received October 15, 2025

    Report

    Report Number
    3007305485-2025-00170
    Event Type
    Injury
    Date Received
    October 15, 2025
    Report Date
    November 3, 2025
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE RETURNED DEVICE COULD NOT CONFIRM THE REPORTED PROBLEM. ADDITIONAL PROBLEMS FOUND THAT THE HARDWARE NEEDED UPGRADE. THE EVALUATION WAS COMPLETED AND FINAL TESTED. THE UNIT MET ALL SPECIFICATIONS. THE PREVENTIVE MAINTENANCE WAS OVERDUE AND COMPLETED AS PART OF THIS REPAIR ORDER. THE SERVICE HISTORY WAS REVIEWED, AND NO PRIOR DATA WAS FOUND. A DHR (DEVICE HISTORY RECORD) REVIEW WAS NOT CONDUCTED AS THE DEVICE HAS BEEN IN THE FIELD GREATER THAN 12 MONTHS. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: THE HYFRECATOR® 2000 IS CAPABLE OF CAUSING PHYSIOLOGICAL EFFECTS, INCLUDING BURNS TO THE PATIENT OR OPERATOR. THE HYFRECATOR® 2000 SHOULD BE TESTED BY QUALIFIED SERVICE PERSONNEL ON A PERIODIC BASIS. CONMED SUGGESTS EXAMINATION OF THE UNIT AT LEAST EVERY 12 MONTHS. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    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 PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY. H3 OTHER TEXT : DEVICE NOT YET RECEIVED

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, 7-900-115, HYFRECATOR 2000, 115V/50-60HZ WAS BEING USED ON AN UNKNOWN DATE AND THE PATIENT RECEIVED A BURN. NO FURTHER INFORMATION IS KNOWN. A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, NO INFORMATION HAS BEEN OBTAINED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF PATIENT BURN OF UNKNOWN DEGREE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, 7-900-115, HYFRECATOR 2000, 115V/50-60HZ WAS BEING USED ON AN UNKNOWN DATE AND THE PATIENT RECEIVED A BURN. NO FURTHER INFORMATION IS KNOWN. A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, NO INFORMATION HAS BEEN OBTAINED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF PATIENT BURN OF UNKNOWN DEGREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2791381 HYFRECATOR 2000 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other