BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYFRECATOR 2000, 115V

    MDR report key: 11849022 · Received May 19, 2021

    Report

    Report Number
    3007305485-2021-00218
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    April 22, 2021
    Report Date
    June 23, 2021
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMERS REPORTED INCIDENT OF THE DEVICE GIVING OFF A SHOCK IS UNCONFIRMED. AN EVALUATION OF THE RETURNED DEVICE FOUND NO FAULT ALTHOUGH THE PREVENTATIVE MAINTENANCE WAS OVERDUE. THE SERVICE HISTORY WAS REVIEWED AND NO PREVIOUS SERVICE DATA WAS FOUND. A REVIEW OF THE DHR FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 19 COMPLAINTS, REGARDING 19 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. (B)(4). AS THIS IS A REUSABLE DEVICE, THE POTENTIAL NUMBER OF USES IS NOT CONSIDERED IN THIS FAILURE 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 THAT THE POWER CORD OF THE ESU SHOULD BE CONNECTED TO A PROPERLY POLARIZED AND GROUNDED POWER SOURCE WHOSE VOLTAGE AND FREQUENCY CHARACTERISTICS ARE COMPATIBLE WITH THOSE LISTED ON THE NAMEPLATE OF THIS ESU. TO AVOID THE RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAIN WITH PROTECTIVE EARTH. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    AT TIME OF FILING, ALTHOUGH EXPECTED, THE REPORTED DEVICE HAS NOT BEEN RECEIVED INTO CONMED'S COMPLAINT SYSTEM 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 · 1

    CONMED RECEIVED NOTIFICATION VIA PHONE OF REPORTED ISSUES WITH A HYFRECATOR 2000, ITEM # 7-900-115, SN (B)(4) THAT OCCURRED AT MD (B)(6) CANCER CENTER/ (B)(6) ON (B)(6) 2021. IT WAS REPORTED ONLY "SHOCKED BY UNIT". IT IS INDICATED THE INCIDENT OCCURRED DURING SURGERY AND THERE WAS NO IMPACT OR INJURY TO THE USER OR PATIENT. ADDITIONAL INFORMATION RECEIVED NOTES THE DOCTOR WAS USING THE HYFRECATER TO CAUTERIZE SKIN BIOPSY SITE. THE DOCTOR WAS STANDING NEXT TO PATIENT ON EXAM ROOM FLOOR WHILE THE PATIENT WAS IN EXAM CHAIR. THE DOCTOR FELT A MILD JOLT FROM THE UNIT. NO MEDICAL TREATMENT WAS NEEDED AS A RESULT OF THE ISSUE. THERE WERE NO ALARMS FROM THE UNIT WHICH WAS PLUGGED INTO ELECTRICAL OUTLET IN WALL, HOSPITAL GRADE AND BEING USED WITH THE SUPPLIED CONMED POWER CORD. NO OTHER ACCESSORIES WERE BEING USED AT THE TIME. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO IMPACT TO THE PATIENT AND NO LASTING IMPACT TO THE DOCTOR. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY AS THE DOCTOR WAS "SHOCKED" .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744259 HYFRECATOR 2000, 115V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other