BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR 2000, 230V

    MDR report key: 12518045 · Received September 23, 2021

    Report

    Report Number
    3007305485-2021-00377
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    August 26, 2021
    Report Date
    November 16, 2021
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE RETURNED DEVICE FOUND NO FAULT. THE UNIT WAS TESTED AND MEETS ALL SPECIFICATIONS. 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 DATA WAS FOUND. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 4 COMPLAINTS, REGARDING 4 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 THAT THE HYFRECATOR 2000 IS CAPABLE OF CAUSING PHYSIOLOGICAL EFFECTS, INCLUDING BURNS TO THE PATIENT OR OPERATOR. 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. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, 7-900-230, WAS BEING USED DURING A CURETTAGE LESION AND CAUTERIZATION OF MID BACK PROCEDURE ON (B)(6) 2021 WHEN IT WAS REPORTED ¿THE SWITCHING PENCIL BECAME HOT AND THE BURST INTO FLAMES DURING A BIOPSY SESSION.¿. INITIALLY IT WAS REPORTED THAT THE DOCTOR HAD SUSTAINED BURNS ON THEIR FEET FROM FALLING DEBRIS FROM THEIR GLOVE. THE PATIENT WAS REPORTED AS HAVING HAD NO INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION. FURTHER ASSESSMENT QUESTIONING FOUND THAT THERE WAS NO INJURY TO THE DOCTOR OR THE PATIENT. THE DOCTOR HAD A ¿VERY MINOR BURN (2MM)¿ WHICH DID NOT REQUIRE ANY MEDICAL INTERVENTION. THE REPORTER STATED ¿EVERYTHING NORMAL, NO INJURY¿ AS AN ANSWER TO THE ASSESSMENT QUESTIONS. THERE WAS NO DELAY REPORTED IN THE COMPLETION OF THE PROCEDURE. THE REPORTER STATED THAT THE PENCIL WAS IN CONTACT WITH BODILY FLUIDS AND TISSUE AT THE TIME OF THE INCIDENT. THE PATIENT¿S SKIN HAD BEEN PREPPED WITH ALCOHOL. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    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. DEVICE NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE, 7-900-230, WAS BEING USED DURING A CURETTAGE LESION AND CAUTERIZATION OF MID BACK PROCEDURE ON (B)(6) 2021 WHEN IT WAS REPORTED ¿THE SWITCHING PENCIL BECAME HOT AND THE BURST INTO FLAMES DURING A BIOPSY SESSION.¿ INITIALLY IT WAS REPORTED THAT THE DOCTOR HAD SUSTAINED BURNS ON THEIR FEET FROM FALLING DEBRIS FROM THEIR GLOVE. THE PATIENT WAS REPORTED AS HAVING HAD NO INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION. FURTHER ASSESSMENT QUESTIONING FOUND THAT THERE WAS NO INJURY TO THE DOCTOR OR THE PATIENT. THE DOCTOR HAD A ¿VERY MINOR BURN (2MM)¿ WHICH DID NOT REQUIRE ANY MEDICAL INTERVENTION. THE REPORTER STATED ¿EVERYTHING NORMAL, NO INJURY¿ AS AN ANSWER TO THE ASSESSMENT QUESTIONS. THERE WAS NO DELAY REPORTED IN THE COMPLETION OF THE PROCEDURE. THE REPORTER STATED THAT THE PENCIL WAS IN CONTACT WITH BODILY FLUIDS AND TISSUE AT THE TIME OF THE INCIDENT. THE PATIENT¿S SKIN HAD BEEN PREPPED WITH ALCOHOL. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416325 HYFRECATOR 2000, 230V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 Female