BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USA ELITE/USA SERIES DISPOSABLE ACTIVE CORD

    MDR report key: 282652 · Received June 19, 2000

    Report

    Report Number
    1519132-2000-00029
    Event Type
    Malfunction
    Date Received
    June 19, 2000
    Date of Event
    May 18, 2000
    Report Date
    June 19, 2000
    Manufacturer
    CIRCON ACMI
    Product Code
    FFZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN ENDOMETRIAL ABLATION, THE DISPOSABLE ACTIVE CORD REPORTEDLY STARTED SMOKING AND BURNED THE WORKING ELEMENT. THE PT WAS NOT BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USA ELITE/USA SERIES DISPOSABLE ACTIVE CORD ACTIVE CORD FFZ CIRCON ACMI DAC CC (3/99)

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO IWE(IGLESIAS WORKING ELEMENT)| RE/GRE, BALL ELECTRODE [CB (3/98)], IWE, IGLESIAS| WORKING ELEMENT [HU (8/92)