BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR 2000, 115V

    MDR report key: 12021909 · Received June 17, 2021

    Report

    Report Number
    3007305485-2021-00305
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    April 23, 2021
    Report Date
    August 27, 2021
    Manufacturer
    CONMED CHIHUAHUA
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DATE OF MANUFACTURE IS LISTED AS 2014. MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED FOR EVALUATION TO DATE AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. WHEN THE DEVICE IS RETURNED, AN EVALUATION WILL BE PERFORMED, AND THE EVENT FILE WILL BE UPDATED. A DEVICE HISTORY RECORD REVIEW WAS NOT CONDUCTED AS THE DEVICE HAS BEEN IN THE FIELD GREATER THAN 12 MONTHS, YEAR OF MANUFACTURE: 2014. THE SERVICE HISTORY WAS REVIEWED, AND NO DATA WAS FOUND. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 6 COMPLAINTS, REGARDING 6 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(6) 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 0.0000003. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT TO AVOID THE RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH. TO AVOID ALTERNATE SITE BURNS OR POTENTIAL SHOCK, REMOVE ALL METAL OBJECTS FROM THE TREATMENT AREA BEFORE USING THE HYFRECATOR 2000. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5101216) ON (B)(6) 2021. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 7-900-115, STATING ¿MALE PATIENT IN CLINIC FOR BILATERAL VASECTOMY. GROUNDING PAD PLACED ON THIGH; PATIENT FELT SHOCK FROM PAD. HYFRECATOR TURNED DOWN AND AGAIN PATIENT FELT SHOCK FROM PAD. IMMEDIATELY DISCONTINUED USE. PATIENT RETURNED TO CLINIC AFTER DISCHARGE C/O SHOOTING PAIN IN HIS BACK. EVALUATED BY PROVIDER AND DISCHARGED TO HOME.¿. THERE WAS NO REPORT OF INJURY TO THE PATIENT PER THE MEDWATCH RECEIVED. UPON FURTHER ASSESSMENT QUESTIONING IT WAS FOUND THAT THE PROCEDURE HAD BEEN COMPLETED USING A DISPOSABLE CAUTERY PEN, UNKNOWN MANUFACTURER, AND LOT NUMBER. AND, THAT THE PATIENT¿S LOWER BACK PAIN WAS BEING RESOLVED WITHOUT MEDICAL INTERVENTION. THE PATIENT PLATE USED, 7-900-7, WAS ALSO A CONMED DEVICE; HOWEVER, NO MALFUNCTION OF THIS DEVICE WAS REPORTED. THEREFORE, THE DEVICE WILL BE LISTED AS A CONCOMITANT DEVICE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5101216) ON (B)(6) 2021. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 7-900-115, STATING ¿MALE PATIENT IN CLINIC FOR BILATERAL VASECTOMY. GROUNDING PAD PLACED ON THIGH; PATIENT FELT SHOCK FROM PAD. HYFRECATOR TURNED DOWN AND AGAIN PATIENT FELT SHOCK FROM PAD. IMMEDIATELY DISCONTINUED USE. PATIENT RETURNED TO CLINIC AFTER DISCHARGE C/O SHOOTING PAIN IN HIS BACK. EVALUATED BY PROVIDER AND DISCHARGED TO HOME.¿. THERE WAS NO REPORT OF INJURY TO THE PATIENT PER THE MEDWATCH RECEIVED. UPON FURTHER ASSESSMENT QUESTIONING IT WAS FOUND THAT THE PROCEDURE HAD BEEN COMPLETED USING A DISPOSABLE CAUTERY PEN, UNKNOWN MANUFACTURER, AND LOT NUMBER. AND, THAT THE PATIENT¿S LOWER BACK PAIN WAS BEING RESOLVED WITHOUT MEDICAL INTERVENTION. THE PATIENT PLATE USED, 7-900-7, WAS ALSO A CONMED DEVICE; HOWEVER, NO MALFUNCTION OF THIS DEVICE WAS REPORTED. THEREFORE, THE DEVICE WILL BE LISTED AS A CONCOMITANT DEVICE. 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
    911252 HYFRECATOR 2000, 115V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED CHIHUAHUA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR 7-900-7 ASSY, PATIENT PLATE| 7-900-7 ASSY, PATIENT PLATE