BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR 2000, 230V

    MDR report key: 11030266 · Received December 17, 2020

    Report

    Report Number
    3007305485-2020-00554
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 27, 2020
    Report Date
    July 21, 2021
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION HAS NOW BEEN RECEIVED AND EVALUATED BY CONMED WHICH CONFIRMED THE CUSTOMER'S REPORTED COMPLAINT OF THE DEVICE CAUGHT FIRE. CONMED RECEIVED ONE 7-900-230 IN ORIGINAL PACKAGING. THE SERIAL NUMBER WAS VERIFIED, AND A VISUAL INSPECTION WAS PERFORMED. THERE IS MELTING AND BURNED STRIATIONS ON THE OUTSIDE OF THE UNIT. THE BURNING STRIATIONS STEM FROM THE P/P OUTLET ON THE FRONT OF THE BOX. THE CORD THAT PLUGS INTO THE P/P OUTLET WAS MELTED WITH A PORTION OF THE PLUG MELTED INTO THE OUTLET. INTERNALLY THERE IS NO EVIDENCE THAT POINTS TO THE UNIT BEING THE CAUSE OF THE FIRE. THE RETURNED UNIT EXHIBITS THE REPORTED CLAIM HOWEVER A ROOT CAUSE CANNOT BE ESTABLISHED. THE REST OF THE INFORMATION AND FINDINGS PREVIOUSLY SUBMITTED IN MANUFACTURER NARRATIVE REMAIN CORRECT AND UNCHANGED AND ARE INCLUDED BELOW. THE SERVICE HISTORY WAS REVIEWED, AND NO DATA WAS FOUND. AT THE TIME OF THE COMPLAINT, THE DEVICE WAS 37 MONTHS OF AGE, BASED UPON THE SERVICE HISTORY, THE PREVENTATIVE MAINTENANCE IS OVERDUE. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD WERE NOT REVIEWED AS THE DEVICE HAS BEEN IN THE FIELD MORE THAN 12 MONTHS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 10 COMPLAINTS, REGARDING 10 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). AS THIS IS A REUSABLE DEVICE, THE POTENTIAL NUMBER OF USES IS NOT CONSIDERED IN THIS OCCURRENCE RATE. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE USER WITH INFORMATION REGARDING PROPER CARE AND USE OF THIS DEVICE. THE IFU ALSO ADVISES THE USER TO VERIFY THAT THE HYFRECATOR 2000 IS THE CORRECT MAINS VOLTAGE AND FREQUENCY BY CHECKING THE SERIAL NUMBER PLATE ON THE BACK OF THE UNIT. ADDITIONALLY, THE IFU ADVISES THE USER THAT THE DEVICE SHOULD BE TESTED BY QUALIFIED SERVICE PERSONNEL ON A PERIODIC BASIS. CONMED SUGGESTS EXAMINATION OF THE UNIT AT LEAST EVERY 12 MONTHS. ADDITIONALLY, CONMED ENCOURAGES THE INSPECTION AND/OR TEST OF ALL MEDICAL EQUIPMENT PRIOR TO USE TO ENSURE ALL DEVICES ARE FUNCTIONING AS EXPECTED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT OF THE DEVICE CAUGHT FIRE IS CONFIRMED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION HOWEVER PHOTOGRAPHIC EVIDENCE HAS BEEN PROVIDED. THE IMAGE EXHIBITS THE REPORTED CLAIM HOWEVER A ROOT CAUSE CANNOT BE ESTABLISHED OTHER THAN THE DEVICE IS OVERDUE FOR PREVENTATIVE MAINTENANCE. THE SERVICE HISTORY WAS REVIEWED, AND NO DATA WAS FOUND. AT THE TIME OF THE COMPLAINT, THE DEVICE WAS 37 MONTHS OF AGE, BASED UPON THE SERVICE HISTORY, THE PREVENTATIVE MAINTENANCE IS OVERDUE. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD WERE NOT REVIEWED AS THE DEVICE HAS BEEN IN THE FIELD MORE THAN 12 MONTHS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 10 COMPLAINTS, REGARDING 10 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD (B)(4). AS THIS IS A REUSABLE DEVICE, THE POTENTIAL NUMBER OF USES IS NOT CONSIDERED IN THIS OCCURRENCE RATE. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE USER WITH INFORMATION REGARDING PROPER CARE AND USE OF THIS DEVICE. THE IFU ALSO ADVISES THE USER TO VERIFY THAT THE HYFRECATOR 2000 IS THE CORRECT MAINS VOLTAGE AND FREQUENCY BY CHECKING THE SERIAL NUMBER PLATE ON THE BACK OF THE UNIT. ADDITIONALLY, THE IFU ADVISES THE USER THAT THE DEVICE SHOULD BE TESTED BY QUALIFIED SERVICE PERSONNEL ON A PERIODIC BASIS. CONMED SUGGESTS EXAMINATION OF THE UNIT AT LEAST EVERY 12 MONTHS. ADDITIONALLY, CONMED ENCOURAGES THE INSPECTION AND/OR TEST OF ALL MEDICAL EQUIPMENT PRIOR TO USE TO ENSURE ALL DEVICES ARE FUNCTIONING AS EXPECTED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    AT TIME OF FILING, THE REPORTED DEVICE IS NOT EXPECTED TO BE RETURNED TO CONMED FOR EVALUATION. THIS REPORTED EVENT IS ENTERING THE INVESTIGATION PROCESS. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ISSUES INVOLVING THE HYFRECATOR 2000, 230V, ITEM # 7-900-230, SERIAL (B)(4) EXPERIENCED (B)(6) 2020 AT (B)(6) MEDIAL PRACTICE, (B)(6). IT WAS REPORTED THAT THE DOCTOR HAD FINISHED COMPLETING THE SECOND VASECTOMY PROCEDURE OF THE DAY ON A PATIENT. THE PATIENT TURNED TO THE DOCTOR AND INDICATED "YOU ARE ON FIRE". THE DOCTOR TURNED TO THE HYFRECATOR UNIT AND SAW FLAMES WERE BILLOWING OUT OF THE CENTER OF THE DEVICE, WHERE THE EARTHING PLATE WIRE CONNECTS TO THE DEVICE. THE DOCTOR EXTINGUISHED THE FLAMES USING GAUZE, TURNED THE ELECTRICAL APPARATUS OFF, AND CONTINUED MANAGING THE PATIENT WHO REMAINED CALM AND WAS UNINJURED. AFTER THE PATIENT LEFT, THE DOCTOR INVESTIGATED WHAT HAD HAPPENED BUT COULD FIND NO OBVIOUS REASON FOR THE FIRE. DURING THIS PATIENT'S VASECTOMY PROCEDURE, THE DOCTOR, AS IS HIS STANDARD PRACTICE, HAD BEEN USING THE HYFRECATOR ON "HIGH", AT A SETTING LEVEL OF 12. AT THE VERY END OF THIS PROCEDURE HE HAD USED THE HYFRECATOR AT LEVEL 22 BRIEFLY TO CAUTERIZE A SMALL VAS BLEED AND THEN HAD REVERTED TO USING IT AT LEVEL 12 TO COMPLETE THE PROCEDURE. THE PATIENT WAS CLEANED WITH "UNISEPT" CHLORHEXIDINE SOLUTION AND THE EQUIPMENT HAD BEEN CLEANED WITH A CLINELL WIPE BEFORE THIS PROCEDURE. AS PER THE DOCTOR, NEITHER CONTAIN ANY ALCOHOL. IT WAS CONFIRMED THAT THE PATIENT WASN'T INJURED AND DIDN'T REQUIRE HOSPITALIZATION, THE PROCEDURE HAD BEEN SUCCESSFULLY COMPLETED. NO OTHER INFORMATION WAS MADE AVAILABLE. 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
    1494920 HYFRECATOR 2000, 230V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT

    Patients

    Seq Age Sex Outcome Treatment
    1