BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR 2000

    MDR report key: 20726809 · Received November 19, 2024

    Report

    Report Number
    3007305485-2024-00181
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Report Date
    January 7, 2025
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    REPORTED EVENT OF THE FAILURE WITH THE DEVICE SHOCKING THE USER IS UNCONFIRMED. THE DEVICE WAS OVERDUE FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS TESTED AND MET ALL SPECIFICATIONS. THE DEVICE DID RECEIVE AN UPGRADED CABLE CONNECTOR AND HEATSINK. THE FINAL TEST WAS COMPLETED, AND THE UNIT MET ALL SPECIFICATIONS. THE SERVICE HISTORY WAS REVIEWED, AND NO PRIOR DATA WAS FOUND. BASED ON THE SERIAL NUMBER, THE DEVICE WAS MANUFACTURED IN 2001. (B)(4). 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: AVOID ALTERNATE SITE BURNS OR POTENTIAL SHOCK, REMOVE ALL METAL OBJECTS FROM TREATMENT AREA BEFORE USING THE HYFRECATOR® 2000. IT IS NOT ADVISABLE TO USE THIS INSTRUMENT IN THE PROXIMITY OF JEWELRY, EYEGLASSES, DIGITAL WATCHES, PORTABLE RADIOS, POCKET CALCULATORS, HEARING AIDS, ETC. THE HYFRECATOR® 2000 SHOULD BE TESTED BY QUALIFIED SERVICE PERSONNEL ON A PERIODIC BASIS. CONMED SUGGESTS EXAMINATION OF THE UNIT AT LEAST EVERY 12 MONTHS.NOTE: ALL INTERNAL SERVICE SHOULD BE PERFORMED BY QUALIFIED SERVICE PERSONNEL ONLY. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE 7-900-115, HYFRECATOR 2000, 115V/50-60HZ, WAS BEING USED ON AN UNKNOWN DATE AND THE PATIENT AND USER WERE ELECTROCUTED. THERE WAS NO REPORT OF IMPACT OR INJURY FOR THE PATIENT OR THE USER. PER FURTHER ASSESSMENT IT WAS FOUND THAT "THE PERSON THAT WAS USING THE MACHINE HAS SINCE LEFT, SO THEY ARE TRYING TO GET A HOLD OF THEM." AND "I HAVE ALREADY CLASSIFIED IT AT OUR END AS A USER-ERROR SINCE THEIR CLAIM COULD NOT BE DUPLICATED IN OUR SHOP." THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE 7-900-115, HYFRECATOR 2000, 115V/50-60HZ, WAS BEING USED ON AN UNKNOWN DATE AND THE PATIENT AND USER WERE ELECTROCUTED. THERE WAS NO REPORT OF IMPACT OR INJURY FOR THE PATIENT OR THE USER. PER FURTHER ASSESSMENT IT WAS FOUND THAT "THE PERSON THAT WAS USING THE MACHINE HAS SINCE LEFT...SO THEY ARE TRYING TO GET A HOLD OF THEM.". AND "I HAVE ALREADY CLASSIFIED IT AT OUR END AS A USER-ERROR SINCE THEIR CLAIM COULD NOT BE DUPLICATED IN OUR SHOP.". 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
    2431366 HYFRECATOR 2000 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown