BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYFRECATOR 2000

    MDR report key: 23308901 · Received October 16, 2025

    Report

    Report Number
    3007305485-2025-00171
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    August 1, 2025
    Report Date
    November 17, 2025
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    UDI-DI
    10653405031598
    PMA / PMN Number
    K970493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT BEING RETURNED AND THE PHOTOGRAPHIC EVIDENCE PROVIDED DOES NOT APPEAR TO VERIFY THE COMPLAINT; THEREFORE, THE REPORTED EVENT 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. THE SERVICE HISTORY WAS REVIEWED AND NO RELATIONSHIP TO THIS COMPLAINT WAS FOUND. (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 AVOID ALTERNATE SITE BURNS OR POTENTIAL SHOCK, REMOVE ALL METAL OBJECTS FROM TREATMENT AREA BEFORE USING THE HYFRECATOR 2000. THE TIPS OF RECENTLY ACTIVATED ACCESSORIES MAY BE HOT ENOUGH TO BURN THE PATIENT OR IGNITE FLAMMABLE MATERIAL. TEMPORARILY UNUSED ACTIVE ELECTRODES SHOULD BE STORED IN THE HOLDER ON THE HYFRECATOR 2000 OR IN AN ELECTRICALLY INSULATED, FLAME-RESISTANT CONTAINER TO PREVENT INJURY DUE TO HOT TIPS OR ACCIDENTAL ACTIVATION OF THE FOOTSWITCH. THE UNUSED ACTIVE ELECTRODE SHOULD NEVER BE PLACED ON THE PATIENT. WHEN USED, THE NEUTRAL ELECTRODE (PATIENT PLATE) SHOULD BE RELIABLY ATTACHED WITH THE ENTIRE SURFACE AREA IN CONTACT WITH THE PATIENT¿S BODY AND AS CLOSE TO THE OPERATING FIELD AS POSSIBLE. WHEN NOT IN USE, THE NEUTRAL ELECTRODE SHOULD BE DISCONNECTED FROM THE HYFRECATOR 2000 TO AVOID ACCIDENTAL BURNS. 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 LIPOMA EXCISION PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿DURING THE PROCEDURE, DR. JING USED OUR HYFRECATOR WHICH CAUSED TWO BURN MARKS ON THE PATIENTS LEFT LEG. A PT WAS INJURED TODAY DURING A LIPOMA EXCISION OF HIS RIGHT TEMPORAL. THIS DEVICE HAS BEEN USED SEVERAL TIMES BY MULTIPLE PROVIDERS AND IS UPDATE WITH INSPECTION. IT IS KEPT SECURELY IN A DRY LOCATION. I AM NOT SURE WHAT COULD BE THE REASON FOR THE MALFUNCTION.". FURTHER ASSESSMENT WAS REQUESTED FROM THE REPORTER, AND THEY STATED THAT NO FURTHER INFORMATION WAS AVAILABLE. THE TYPE OF MALFUNCTION OR RELATIONSHIP BETWEEN THE DEVICE AND HOW THE BURN WAS CAUSED IS NOT KNOWN AT THIS TIME. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY UNKNOWN DEGREE OF BURN TO PATIENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, 7-900-115, HYFRECATOR 2000, 115V/50-60HZ, WAS BEING USED DURING LIPOMA EXCISION PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿DURING THE PROCEDURE, DR. (B)(6) USED OUR HYFRECATOR WHICH CAUSED TWO BURN MARKS ON THE PATIENTS LEFT LEG. A PT WAS INJURED TODAY DURING A LIPOMA EXCISION OF HIS RIGHT TEMPORAL. THIS DEVICE HAS BEEN USED SEVERAL TIMES BY MULTIPLE PROVIDERS AND IS UPDATE WITH INSPECTION. IT IS KEPT SECURELY IN A DRY LOCATION. I AM NOT SURE WHAT COULD BE THE REASON FOR THE MALFUNCTION.". FURTHER ASSESSMENT WAS REQUESTED FROM THE REPORTER, AND THEY STATED THAT NO FURTHER INFORMATION WAS AVAILABLE. THE TYPE OF MALFUNCTION OR RELATIONSHIP BETWEEN THE DEVICE AND HOW THE BURN WAS CAUSED IS NOT KNOWN AT THIS TIME. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY UNKNOWN DEGREE OF BURN TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2392162 HYFRECATOR 2000 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY 10653405031598

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other