BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYFRECATOR 2000

    MDR report key: 2955294 · Received February 11, 2013

    Report

    Report Number
    1720159-2013-00013
    Event Type
    Other
    Date Received
    February 11, 2013
    Date of Event
    July 17, 2012
    Report Date
    February 27, 2013
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE HYFRECATOR 2000 IS BEING HELD BY THE END-USER FACILITY IN THE (B)(6). CONMED IS ATTEMPTING TO HAVE THE DEVICE RETRIEVED TO CONMED UK FOR EVALUATION. CONMED CORPORATION IS ATTEMPTING TO RETRIEVE ADDITIONAL INFORMATION REGARDING THIS REPORTED INCIDENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ON THE COMPLETION OF THE QUALITY ENGINEERING EVALUATION. NOT RETURNED TO CONMED CORP.

    Description of Event or Problem · 1

    IT WAS REPORTED, "HYFRECATOR 2000 - HYFRECATOR SPARKED AND SET ON FIRE. PATIENT UNINJURED. STAFF MEMBER HAD A SHARPS INJURY DUE TO BLADE BEING NEAR FIRE. EQUIPMENT REMOVED FROM SERVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59342 HYFRECATOR 2000 HYFRECATOR ESU GEI CONMED ELECTROSURGERY N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| O
    1 NA Unknown Other| O