BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR 2000, 115V

    MDR report key: 10791328 · Received November 5, 2020

    Report

    Report Number
    3007305485-2020-00472
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 16, 2020
    Report Date
    January 13, 2021
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS MELTED ON THE TOP AND LOWER CASE. THE CONTROLLER BOARD IS BURN BECAUSE OF A DEFECTIVE PENCIL. PARTS WERE REPLACED AND NEW S/N LABEL WAS GENERATED. THE UNIT WAS FINAL TESTED AND MET ALL SPECIFICATIONS. THE SERVICE HISTORY WAS REVIEWED AND NO PREVIOUS DATA WAS FOUND. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 3 COMPLAINTS, REGARDING 3 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) 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 THAT SAFE AND EFFECTIVE ELECTROSURGERY IS DEPENDENT NOT ONLY ON EQUIPMENT DESIGN, BUT ALSO ON FACTORS UNDER THE CONTROL OF THE OPERATOR. IT IS IMPORTANT THE INSTRUCTIONS SUPPLIED WITH THIS EQUIPMENT BE READ, UNDERSTOOD, AND FOLLOWED IN ORDER TO ENSURE SAFE AND EFFECTIVE USE OF THE EQUIPMENT. THE TIPS OF RECENTLY ACTIVATED ACCESSORIES MAY BE HOT ENOUGH TO BURN THE PATIENT OR IGNITE FLAMMABLE MATERIAL. EXERCISE CARE WHEN MOVING THE ESU TO AVOID ELECTROSTATIC CHARGE BUILDUP IN THE PRESENCE OF FLAMMABLE MATERIALS, AS THERE IS A RISK OF IGNITING THESE MATERIALS IF A SPARK SHOULD OCCUR. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    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 · 1

    THE CUSTOMER REPORTED THAT THE DEVICE, 7-900-115, WAS BEING USED DURING AN EXCISION OF SKIN CANCER FROM THE UPPER BACK ON (B)(6) 2020 WHEN IT WAS REPORTED THAT "THE DEVICE WAS IN THE WALL. THE HANDHELD PORTION/PENCIL (UNKNOWN CATALOG/MFG) WAS BEING HELD BY THE SURGEON. THE DEVICE WAS ON SETTING 15 ON THE HIGH SETTING IT WAS BEING USED WHEN THE FIRE STARTED. THE BOTTOM LEFT PORTION OF THE BOX HAD CAUGHT ON FIRE. DISCONNECTING THE HANDHELD PENCIL FROM THE BOX IN THE WALL. THE FIRE WAS ONLY EXCLUSIVE TO THE BOX DEVICE IN THE WALL. THE FIRE ALARM WAS PULLED, AND THE FIRE WAS EXTINGUISHED WITH THE FIRE EXTINGUISHER". THE PROCEDURE WAS COMPLETED IN A DIFFERENT ROOM WITH DIFFERENT EQUIPMENT WHICH CAUSED A 15 TO 20-MINUTE DELAY IN THE PROCEDURE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR HOSPITALIZATION TO THE PATIENT OR USER. THE CURRENT STATUS OF THE PATIENT IS LISTED AS "GOOD". 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
    1258330 HYFRECATOR 2000, 115V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT 11GGJ226

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening HANDHELP PORTION/PENCIL| HANDHELP PORTION/PENCIL