BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR 2000, 115V

    MDR report key: 17058504 · Received June 5, 2023

    Report

    Report Number
    3007305485-2023-00139
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    April 26, 2023
    Report Date
    July 12, 2023
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF ¿THE TIP OF THE HYFRECATOR SPARKED DURING SURGERY¿ IS CONFIRMED. EVALUATION FOUND THAT A NEW HEAT SINK ON A2VR1 WITH A NEW SHAPE WAS REQUIRED. ADDITIONALLY, THE PM WAS OVERDUE. THE TECHNICIAN ALSO INDICATED THAT THE ISSUE COULD BE DUE TO THE PENCIL TOUCHING PATIENT GROUND OR HAS A BAD GROUND. THE DEVICE WAS CALIBRATED AND TESTED PER THE IP AND MET ALL REQUIREMENTS. THE SERVICE HISTORY WAS REVIEWED, AND NO PREVIOUS SERVICE DATA WAS FOUND. A DEVICE HISTORY RECORD REVIEW WAS NOT CONDUCTED 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 13 REPORTS, REGARDING 13 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 THE FOLLOWING: VISUALLY INSPECT ALL ACCESSORIES BEFORE EACH USE TO VERIFY THE INTEGRITY OF INSULATION AND THE ABSENCE OF OBVIOUS DEFECTS. IN PARTICULAR, ELECTRODE CABLES AND ENDOSCOPIC ACCESSORIES SHOULD BE CHECKED FOR DAMAGE TO THE INSULATION. THIS ELECTROSURGICAL UNIT SHOULD BE TESTED BY A HOSPITAL QUALIFIED BIOMEDICAL TECHNICIAN ON A PERIODIC BASIS TO ENSURE PROPER AND SAFE OPERATION. IT IS RECOMMENDED THAT EXAMINATION OF THE ESU BE PERFORMED AT LEAST YEARLY. ADDITIONALLY, THE CONMED RECOMMENDED SERVICE INTERVAL FOR THIS DEVICE IS TWELVE MONTHS. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS BEEN RETURNED TO CONMED; HOWEVER, THE EVALUATION OF THE DEVICE HAS NOT BEEN COMPLETED. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, 7-900-115 HYFRECATOR 2000, 115V WAS BEING USED DURING A SHAVE BIOPSY PROCEDURE ON (B)(6) 2023, WHEN IT WAS REPORTED ¿DR. WAS PERFORMING A SHAVE BIOPSY ON PATIENT¿S LEFT LOWER LEG. SHE USED HIBICLENS SOLUTION TO CLEAN THE AREA, SHE NUMBED AREA WITH LOCAL ANESTHESIA, SHE THEN APPLIED PRESSURE WITH A GAUZE, SHE SHAVED THE AREA, USED DRYSOL WITH A COTTON APPLICATOR TO ATTEMPT TO STOP THE BLEEDING. THE BLEEDING CONTINUED AND THEN SHE PROCEEDED TO CAUTERIZE THE SKIN. THEN, SHE PAT-DRIED THE LEG AGAIN WITH A GAUZE THAT MAY HAVE BEEN SOAKED WITH THE DRYSOL COTTON APPLICATOR. SHE THEN PROCEEDED TO CAUTERIZE THE SKIN AGAIN, THE TIP OF THE HYFRECATOR SPARKED AND THE GAUZE ON HER LEFT HAND CAUGHT ON FIRE. SHE IMMEDIATELY TOSSED THE GAUZE TO THE FLOOR, MEDICAL STUDENT PUT THE FIRE OUT WITH HIS SHOE. PATIENT WAS NOT HURT, DR. DENIES ANY INJURY TO HER LEFT HAND, MEDICAL STUDENT WAS NOT INJURED.¿ THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, 7-900-115 HYFRECATOR 2000, 115V WAS BEING USED DURING A SHAVE BIOPSY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿DR. WAS PERFORMING A SHAVE BIOPSY ON PATIENT¿S LEFT LOWER LEG. SHE USED HIBICLENS SOLUTION TO CLEAN THE AREA, SHE NUMBED AREA WITH LOCAL ANESTHESIA, SHE THEN APPLIED PRESSURE WITH A GAUZE, SHE SHAVED THE AREA, USED DRYSOL WITH A COTTON APPLICATOR TO ATTEMPT TO STOP THE BLEEDING. THE BLEEDING CONTINUED AND THEN SHE PROCEEDED TO CAUTERIZE THE SKIN. THEN, SHE PAT-DRIED THE LEG AGAIN WITH A GAUZE THAT MAY HAVE BEEN SOAKED WITH THE DRYSOL COTTON APPLICATOR. SHE THEN PROCEEDED TO CAUTERIZE THE SKIN AGAIN, THE TIP OF THE HYFRECATOR SPARKED AND THE GAUZE ON HER LEFT HAND CAUGHT ON FIRE. SHE IMMEDIATELY TOSSED THE GAUZE TO THE FLOOR, MEDICAL STUDENT PUT THE FIRE OUT WITH HIS SHOE. PATIENT WAS NOT HURT, DR. DENIES ANY INJURY TO HER LEFT HAND, MEDICAL STUDENT WAS NOT INJURED.¿ 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
    218340 HYFRECATOR 2000, 115V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown