BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR 2000, 230V

    MDR report key: 15707586 · Received November 1, 2022

    Report

    Report Number
    3007305485-2022-00168
    Event Type
    Malfunction
    Date Received
    November 1, 2022
    Date of Event
    September 30, 2022
    Report Date
    December 22, 2022
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT, ¿MILD BURN,¿ IS CONFIRMED BASED ON DEVICE EVALUATION. EVALUATION OF THE DEVICE FOUND WHEN ACTIVATE UNIT SHOWED ERROR (ERR -6 OR -F), RIBBON CABLE A2W1 IS BROKEN, AND FRONT COVER IS BROKEN. A DHR REVIEW WAS NOT CONDUCTED AS THE DEVICE HAS BEEN IN THE FIELD GREATER THAN 12 MONTHS. THE SERVICE HISTORY WAS REVIEWED, AND NO PRIOR DATA WAS FOUND. (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. TO 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. THE OUTPUT POWER SELECTED SHOULD BE AS LOW AS POSSIBLE AND ACTIVATION TIMES SHOULD BE AS SHORT AS POSSIBLE TO ACHIEVE THE DESIRED SURGICAL EFFECT. SKIN TO SKIN CONTACT (FOR EXAMPLE, BETWEEN THE ARMS AND BODY OF THE PATIENT) SHOULD BE AVOIDED BY THE INSERTION OF DRY GAUZE OR OTHER SUITABLE MEANS. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE 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. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 7-900-230, HYFRECATOR 2000, 230V, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿HYFRECATOR WAS BEING USED ON A PATIENT WHEN THE PEN BECAME HOT IN THE CLINICIAN¿S HAND, A PIECE OF GAUZE ON THE PATIENT ALSO BECAME HOT, ALTHOUGH NOT IN CONTACT WITH THE PEN, THIS CAUSED A REACTION, AND THE PATIENT RECEIVED A MILD BURN. THE NORMAL CLEANING SOLUTION WAS USED AND SHOULD HAVE BEEN DRIED OFF BEFORE USE OF THE HYFRECATOR. ALSO, IT WAS STANDARD GAUZE, WITH NO FLAMMABLE PRODUCT IMPREGNATED INTO THE GAUZE. THE PATIENT PLATE WAS NOT BEING USED." FURTHER ASSESSMENT QUESTIONING FOUND THAT THE PATIENT OBTAINED A SUPERFICIAL BURN ON HIS BACK AND A BURN GEL DRESSING WAS APPLIED FOR TREATMENT. THE PROCEDURE WAS COMPLETED, AND THE PATIENT STATUS WAS REPORTED AS ¿OK¿. THERE WAS NO EXTENDED HOSPITALIZATION, OR SURGICAL INTERVENTION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION DUE TO PATIENT SUSTAINING A 1ST DEGREE BURN.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 7-900-230, HYFRECATOR 2000, 230V, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿HYFRECATOR WAS BEING USED ON A PATIENT WHEN THE PEN BECAME HOT IN THE CLINICIAN¿S HAND, A PIECE OF GAUZE ON THE PATIENT ALSO BECAME HOT, ALTHOUGH NOT IN CONTACT WITH THE PEN, THIS CAUSED A REACTION, AND THE PATIENT RECEIVED A MILD BURN. THE NORMAL CLEANING SOLUTION WAS USED AND SHOULD HAVE BEEN DRIED OFF BEFORE USE OF THE HYFRECATOR. ALSO, IT WAS STANDARD GAUZE, WITH NO FLAMMABLE PRODUCT IMPREGNATED INTO THE GAUZE. THE PATIENT PLATE WAS NOT BEING USED." FURTHER ASSESSMENT QUESTIONING FOUND THAT THE PATIENT OBTAINED A SUPERFICIAL BURN ON HIS BACK AND A BURN GEL DRESSING WAS APPLIED FOR TREATMENT. THE PROCEDURE WAS COMPLETED, AND THE PATIENT STATUS WAS REPORTED AS ¿OK¿. THERE WAS NO EXTENDED HOSPITALIZATION, OR SURGICAL INTERVENTION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION DUE TO PATIENT SUSTAINING A 1ST DEGREE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856448 HYFRECATOR 2000, 230V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY 10KGJ388

    Patients

    Seq Age Sex Outcome Treatment
    1 Male