BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYFRECATOR 2000, 115V

    MDR report key: 18466439 · Received January 8, 2024

    Report

    Report Number
    3007305485-2024-00003
    Event Type
    Injury
    Date Received
    January 8, 2024
    Date of Event
    December 11, 2023
    Report Date
    February 7, 2024
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION FOUND THAT THE UNIT WAS CHECKED AND MET ALL ACCEPTANCE CRITERION; NO FAULT FOUND. THE PM WAS COMPLETED; THE DEVICE WAS FINAL TESTED AND MET ALL SPECIFICATIONS. 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 FOR MORE THAN 12 MONTHS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF TWO REPORTS, REGARDING TWO 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: 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. THE IFU ALSO ADVISES THE USER THAT WHEN USED, THE NEUTRAL ELECTRODE (PATIENT PLATE) SHOULD BE RELIABLY ATTACHED WITH THE ENTIRE SURFACE AREA IN CONTACT WITH THE PATIENT¿S BODY AND AS CLOSE TO THE OPERATING FIELD AS POSSIBLE. WE WILL CONTINUE TO MONITOR FOR TRENDS 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. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY. H3 OTHER TEXT: DEVICE NOT YET RECEIVED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE 7-900-115, HYFRECATOR 2000, 115V WAS BEING USED ON (B)(6) 2023 AND THE PATIENT WAS BURNED. FURTHER ASSESSMENT WAS SENT; HOWEVER, THE RESPONSE WAS "UNFORTUNATELY, THE VA PRIVACY OFFICER HAS ADVISED THAT I NOT PROVIDE THE PATIENT OR EVENT INFORMATION AS IT IS PROTECTED UNDER 38 U.S.C 570¿. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF BURN OF UNKNOWN DEGREE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE 7-900-115, HYFRECATOR 2000, 115V WAS BEING USED ON (B)(6) 2023 AND THE PATIENT WAS BURNED. FURTHER ASSESSMENT WAS SENT; HOWEVER, THE RESPONSE WAS "UNFORTUNATELY, THE (B)(6) PRIVACY OFFICER HAS ADVISED THAT I NOT PROVIDE THE PATIENT OR EVENT INFORMATION AS IT IS PROTECTED UNDER 38 U.S.C 570¿. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF BURN OF UNKNOWN DEGREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600048 HYFRECATOR 2000, 115V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other