BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR 2000, 115V

    MDR report key: 12780647 · Received November 9, 2021

    Report

    Report Number
    3007305485-2021-00410
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 26, 2021
    Report Date
    December 30, 2021
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WAS CHANGED FROM YES TO NO. MANUFACTURER NARRATIVE: REPORTED EVENT IS INCONCLUSIVE. THE DEVICE IS NOT BEING RETURNED AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED FAILURE COULD NOT BE VERIFIED. THE SERVICE HISTORY WAS REVIEWED AND NO RELATIONSHIP TO THIS COMPLAINT WAS FOUND. A REVIEW OF THE DEVICE HISTORY REVIEW WAS NOT PERFORMED SINCE 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 17 COMPLAINTS, REGARDING 17 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: TO AVOID THE RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH. THIS ISSUE WILL CONTINUE TO BE MONITORED 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. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY. .

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE, 7-900-115, HYFRECATOR 2000, 115V, DEVICE SHOCKED THE NURSE DURING PRE-OPERATIVE TESTING ON APPROXIMATELY 26OCT21. THERE WAS NO INJURY/IMPACT TO THE NURSE. FURTHER ASSESSMENT WAS SENT; HOWEVER, THE RESPONSE FROM THE REPORTER WAS ¿THIS IS ALL SET.¿ THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE, 7-900-115, HYFRECATOR 2000, 115V, DEVICE SHOCKED THE NURSE DURING PRE-OPERATIVE TESTING ON APPROXIMATELY (B)(6) 2021. THERE WAS NO INJURY/IMPACT TO THE NURSE. FURTHER ASSESSMENT WAS SENT; HOWEVER, THE RESPONSE FROM THE REPORTER WAS ¿THIS IS ALL SET.¿ 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
    1675975 HYFRECATOR 2000, 115V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown