BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR 2000, 115V

    MDR report key: 7527445 · Received May 18, 2018

    Report

    Report Number
    3007305485-2018-00124
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    April 24, 2018
    Report Date
    July 3, 2018
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED UPON COMPLETION OF THE PRODUCT EVALUATION AND THE COMPLAINT INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ALTHOUGH MULTIPLE ATTEMPTS WERE MADE, NO INFORMATION REGARDING THE PATIENT STATUS OR PROCEDURE WAS MADE AVAILABLE. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE HAS BEEN PROVIDED; THEREFORE, THE REPORTED FAILURE COULD NOT BE VERIFIED AND A ROOT CAUSE CANNOT BE DETERMINED. THE SERVICE HISTORY OF THIS DEVICE WAS REVIEWED AND NO DATA WAS FOUND. A REVIEW OF THE MANUFACTURING DOCUMENTS VERIFIED THE DEVICE WAS PRODUCED PER CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED 2 OTHER SIMILAR COMPLAINTS FOR THIS PRODUCT FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME, (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE, MAKING THE RATE OF OCCURRENCE OF THIS FAILURE (B)(4) PERCENT, IF ALL COMPLAINTS WERE CONFIRMED. THE INSTRUCTIONS FOR USE ADVISES THE USER OF THE FOLLOWING. ELECTROSURGERY SHOULD NEVER BE PERFORMED IN THE PRESENCE OF FLAMMABLE ANESTHETICS, FLAMMABLE PREP SOLUTIONS OR DRAPES, OXIDIZING GASES SUCH AS NITROUS OXIDE, OR IN OXYGEN-ENRICHED ENVIRONMENTS. THE RISK OF IGNITING FLAMMABLE GASES OR OTHER MATERIAL IS INHERENT IN ELECTROSURGERY AND CANNOT BE ELIMINATED BY DEVICE DESIGN. PRECAUTIONS MUST BE TAKEN TO RESTRICT FLAMMABLE MATERIALS AND SUBSTANCES FROM THE ELECTROSURGICAL SITE, WHETHER THEY ARE PRESENT IN THE FORM OF AN ANESTHETIC, LIFE SUPPORT, SKIN PREPARATION AGENT, OR ARE PRODUCED BY NATURAL PROCESSES WITHIN BODY CAVITIES, OR ORIGINATE IN SURGICAL DRAPES, TRACHEAL TUBES, OR OTHER MATERIALS. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE USING A 7-900-115 HYFRECATOR 2000, FIRE OCCURED WHILE REMOVING A SKIN CELL. THE FIRE WAS CONTAINED, AND NO INJURY TO THE PATIENT OR THE STAFF WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A 3 MINUTE SURGICAL DELAY. ALTHOUGH MULTIPLE ATTEMPTS HAVE BEEN MADE, NO ADDITIONAL INFORMATION REGARDING PATIENT STATUS OR PROCEDURE HAS BEEN PROVIDED. THIS REPORT IS BEING RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367544 HYFRECATOR 2000, 115V HYFRECATOR EQUIPMENT GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1