BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR 2000, 230V

    MDR report key: 16751068 · Received April 17, 2023

    Report

    Report Number
    3007305485-2023-00083
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    March 27, 2023
    Report Date
    May 31, 2023
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    UDI-DI
    10653405031611
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE RETURNED DEVICE FOUND BROKEN CONNECTOR PLATE ASSEMBLY AND WAS UNACCEPTABLE TO USE UNIT. THE SERVICE HISTORY WAS REVIEWED, AND NO DATA WAS FOUND. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. (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. TO MINIMIZE THE POSSIBILITY OF SHOCKING DURING MONOTERMINAL APPLICATIONS: DO NOT LET YOUR PATIENT COME IN CONTACT WITH ANY GROUNDED METAL OBJECTS; POSITION THE ELECTRODE ON OR CLOSE TO THE PATIENT BEFORE ACTIVATING THE OUTPUT; FOR PROCEDURES USING THE DISPERSIVE PLATE, DO NOT ALLOW THE PATIENT TO BREAK CONTACT WITH THE DISPERSIVE PLATE WHEN THE UNIT IS ACTIVATED; IF THE PHYSICIAN OR NURSE MUST TOUCH THE PATIENT, PLACE HAND ON THE PATIENT BEFORE ACTIVATING THE HYFRECATOR® 2000. DO NOT BREAK CONTACT DURING ACTIVATION. TO LESSEN THE POSSIBILITY OF A SHOCK, WEAR GLOVES AT ALL TIMES AND CONTINUE TO AVOID CONTACT WITH GROUNDED METAL OBJECTS. 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. DEVICE NOT YET RECEIVED.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE 7-900-230, HYFRECATOR 2000, 230V DURING PRE-OPERATIVE CHECK ON 27MAR23 SHOCKED A STAFF MEMBER, ¿NO PATIENT PLATE WAS BEING USED.¿. THE PROCEDURE WAS NOT COMPLETED AND THERE WAS NO DELAY REPORTED. AN ALTERNATE DEVICE WAS NOT USED. AFTER FURTHER ASSESSMENT IT WAS FOUND, "THERE WAS NO INJURY TO THE DOCTOR. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THE DOCTOR. THE DOCTOR IS OK". THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE 7-900-230, HYFRECATOR 2000, 230V DURING PRE-OPERATIVE CHECK ON (B)(6) 2023 SHOCKED A STAFF MEMBER, ¿NO PATIENT PLATE WAS BEING USED.¿. THE PROCEDURE WAS NOT COMPLETED AND THERE WAS NO DELAY REPORTED. AN ALTERNATE DEVICE WAS NOT USED. AFTER FURTHER ASSESSMENT IT WAS FOUND, "THERE WAS NO INJURY TO THE DOCTOR. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THE DOCTOR. THE DOCTOR IS OK". 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
    2318913 HYFRECATOR 2000, 230V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY 10653405031611

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown