BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR 2000, 115V

    MDR report key: 8351053 · Received February 19, 2019

    Report

    Report Number
    1720159-2019-00049
    Event Type
    Malfunction
    Date Received
    February 19, 2019
    Report Date
    February 19, 2019
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE, 7-900-115, WAS RETURNED AND EVALUATED. THE DEVICE WAS TESTED PER SPECIFICATION FOR POWER ACCURACY AND OPEN CIRCUIT VOLTAGE AND NO DEFECTS WERE FOUND. THE DEVICE WAS FOUND TO MEET ALL SPECIFICATIONS. THE SALES REPRESENTATIVE WAS ADVISED BY THE ACCOUNT BIOMED TECHNICIAN THAT A GROUNDING PAD WAS NOT BEING USED. THE SALES REPRESENTATIVE HAS ADVISED THE ACCOUNT OF THE APPROPRIATE GROUNDING PAD AS FUTURE ASSISTANCE DURING THE USE OF THIS DEVICE. THE SERVICE HISTORY OF THIS DEVICE WAS REVIEWED AND NO PREVIOUS REPAIRS WERE FOUND. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF (B)(4) COMPLAINTS, REGARDING 3 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: SAFETY PRECAUTIONS AND WARNINGS: IN ALL ELECTRICAL DEVICES WHERE A CURRENT IS EMITTED FROM THE INSTRUMENT, THE CURRENT MUST HAVE A RETURN PATH. THE RETURN PATH FOR MONOTERMINAL APPLICATIONS IS THROUGH THE PATIENT'S BODY, TO THE GROUND AND BACK TO THE INSTRUMENT. IN THIS MODE, IF ANY PORTION OF THE PATIENT'S BODY COMES IN CONTACT WITH A GROUNDED METAL OBJECT, SUCH AS A CHAIR OR METAL RAIL, THE CURRENT WILL TAKE THE PATH OF LEAST RESISTANCE AND A SLIGHT SHOCK MAY BE FELT. 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. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 7-900-115, HYFRECATOR 2000, 115V/50-60HZ, DEVICE WAS BEING USED DURING A PROCEDURE WHERE THE PATIENT WAS HAVING 2 SKIN CYSTS REMOVED ON AN UNKNOWN DATE. THE PATIENT WAS LYING ON THEIR ABDOMEN AND WAS TOUCHING THE METAL ON THE ARM REST. THE DEVICE WAS BEING USED TO COAGULATE SOME BLEEDING IN THE POSTERIOR NECK WOUND. THE PATIENT DID NOT FEEL ANY PAIN EXCEPT A SHOCK IN HIS RIGHT HAND WHERE HE WAS TOUCHING THE METAL ON THE ARM REST. THERE WAS NO BURN REPORTED AND THE PATIENT IS REPORTED AS BEING "FINE NOW". THE PROCEDURE WAS COMPLETED AS NORMAL. THE USER IS REPORTED AS HAVING NOT USED A GROUNDING PAD WITH THE DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION DUE TO THIS EVENT. 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
    143815 HYFRECATOR 2000, 115V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED ELECTROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1