BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR

    MDR report key: 24556604 · Received March 10, 2026

    Report

    Report Number
    3007305485-2026-00034
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    November 11, 2025
    Report Date
    March 27, 2026
    Manufacturer
    CONMED
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEITHER THE DEVICE NOR PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. THE SERVICE HISTORY REVIEW CANNOT BE CONDUCTED AS A SERIAL NUMBER WAS NOT PROVIDED. A DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED AS A SERIAL NUMBER WAS NOT PROVIDED. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: AVOID ALTERNATE SITE BURNS OR POTENTIAL SHOCK, REMOVE ALL METAL OBJECTS FROM TREATMENT AREA BEFORE USING THE HYFRECATOR® 2000. IT IS NOT ADVISABLE TO USE THIS INSTRUMENT IN THE PROXIMITY OF JEWELRY, EYEGLASSES, DIGITAL WATCHES, PORTABLE RADIOS, POCKET CALCULATORS, HEARING AIDS, ETC. IN ALL ELECTRICAL DEVICES WHERE A CURRENT IS EMITTED FROM THE INSTRUMENT, THE CURRENT MUST HAVE A RETURN PATH. THE RETURN PATH FOR MONOTERMINAL APPLICATIONS IS THROUGH THE PATIENT¿S BODY, TO THE GROUND AND BACK TO THE INSTRUMENT. IN THIS MODE, IF ANY PORTION OF THE PATIENT¿S BODY COMES IN CONTACT WITH A GROUNDED METAL OBJECT, SUCH AS A CHAIR OR METAL RAIL, THE CURRENT WILL TAKE THE PATH OF LEAST RESISTANCE AND A SLIGHT SHOCK MAY BE FELT. 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. 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 SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 7-900-230, HYFRECATOR 2000 230 VOLTS AC WAS BEING USED ON 11NOV25 AND ¿A FEW MONTHS AGO, WE EXPERIENCED AN INCIDENT DURING A FACIAL LESION REMOVAL WHERE THE DIATHERMY PAD HAD BEEN CORRECTLY APPLIED (OVER A LARGE MUSCLE MASS WITH CONDUCTIVE GEL). DURING THE PROCEDURE, THE PATIENT EXPERIENCED A SHARP SHOCK SENSATION IN HIS TEETH. FORTUNATELY, HE WAS UNHARMED, BUT UNDERSTANDABLY DISTRESSED. THE INCIDENT WAS RISKMAN REPORTED AND INVESTIGATED. FURTHER REVIEW IDENTIFIED THAT THE PATIENT HAD METAL DENTAL FILLINGS. AFTER DISCUSSION WITH THE DERMATOLOGIST INVOLVED AND SENIOR COLLEAGUES, IT WAS SUGGESTED THAT, FOR FUTURE FACIAL PROCEDURES, PLACING GAUZE INSIDE THE PATIENT¿S MOUTH MAY HELP REDUCE RISK. OUR BIOMEDICAL ENGINEERING TEAM ALSO ADVISED THAT ELECTRICAL CURRENT FOLLOWS THE PATH OF LEAST RESISTANCE BETWEEN THE ACTIVE ELECTRODE AND RETURN PLATE. IN THIS CASE, IT APPEARED THE METAL FILLINGS MAY HAVE PROVIDED A LOWER RESISTANCE PATHWAY DUE TO THEIR PROXIMITY TO THE SURGICAL SITE.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO 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 7-900-230, HYFRECATOR 2000 230 VOLTS AC WAS BEING USED ON (B)(6) 2025 AND ¿A FEW MONTHS AGO, WE EXPERIENCED AN INCIDENT DURING A FACIAL LESION REMOVAL WHERE THE DIATHERMY PAD HAD BEEN CORRECTLY APPLIED (OVER A LARGE MUSCLE MASS WITH CONDUCTIVE GEL). DURING THE PROCEDURE, THE PATIENT EXPERIENCED A SHARP SHOCK SENSATION IN HIS TEETH. FORTUNATELY, HE WAS UNHARMED, BUT UNDERSTANDABLY DISTRESSED. THE INCIDENT WAS RISKMAN REPORTED AND INVESTIGATED. FURTHER REVIEW IDENTIFIED THAT THE PATIENT HAD METAL DENTAL FILLINGS. AFTER DISCUSSION WITH THE DERMATOLOGIST INVOLVED AND SENIOR COLLEAGUES, IT WAS SUGGESTED THAT, FOR FUTURE FACIAL PROCEDURES, PLACING GAUZE INSIDE THE PATIENT¿S MOUTH MAY HELP REDUCE RISK. OUR BIOMEDICAL ENGINEERING TEAM ALSO ADVISED THAT ELECTRICAL CURRENT FOLLOWS THE PATH OF LEAST RESISTANCE BETWEEN THE ACTIVE ELECTRODE AND RETURN PLATE. IN THIS CASE, IT APPEARED THE METAL FILLINGS MAY HAVE PROVIDED A LOWER RESISTANCE PATHWAY DUE TO THEIR PROXIMITY TO THE SURGICAL SITE.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. 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
    616425 HYFRECATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male