BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 2674815 · Received July 24, 2012

    Report

    Report Number
    2320762-2012-00002
    Event Type
    Other
    Date Received
    July 24, 2012
    Date of Event
    June 26, 2012
    Report Date
    July 23, 2012
    Manufacturer
    UNIMED SURGICAL PRODUCTS, INC.
    Product Code
    GEI
    PMA / PMN Number
    K962935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: THE HOSPITAL REPORTED THAT DURING SURGERY THE EXTENDEVAC ELECTROSURGICAL PENCIL WAS PLUGGED INTO THE ESU AND THE COAGULATE WAS IMMEDIATELY ACTIVATED WITHOUT ANY STIMULUS FROM THE HANDPIECE. THE DEVICE WAS UNPLUGGED AND PLUGGED IN SEVERAL TIMES AND THEY COULD NOT GET IT TO WORK OR IT STOPPED WORKING. DEROYAL: THE DEFECTIVE DEVICE IS A VENDOR PURCHASED PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED AT THIS TIME FOR A ROOT CAUSE EVAL.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING SURGERY, THE EXTENDEVAC ELECTROSURGICAL PENCIL WAS PLUGGED INTO THE ESU AND THE COAGULATE WAS IMMEDIATELY ACTIVATED WITHOUT ANY STIMULUS FROM THE HANDPIECE. THE DEVICE WAS UNPLUGGED AND PLUGGED IN SEVERAL TIMES AND THEY COULD NOT GET IT TO WORK OR IT STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL EXTENDEVAC ELECTROSURGICAL PENCIL GEI UNIMED SURGICAL PRODUCTS, INC. 88-015722 24793771

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other