BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPOR TRODE

    MDR report key: 427321 · Received November 11, 2002

    Report

    Report Number
    MW1026703
    Event Type
    Malfunction
    Date Received
    November 11, 2002
    Date of Event
    October 22, 2002
    Report Date
    October 31, 2002
    Manufacturer
    CIRCON CORP.
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE RESECTION OF THE TURP, THE SURGEON DETECTED AN ELECTRICAL BURNING SMELL. THE DAC WAS REPLACED BUT THE SMELL PERSISTED. THE IWE WAS THEN REPLACED WITH THE VES. THE SMELL SUBSIDED. IT WAS THEN NOTED THAT A CHARRED AREA WAS SEEN ON THE WORKING ELEMENT WHERE THE ELECTRODE AND VAPORTRODE CONNECTS. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOR TRODE VAPORIZATION ELECTRODE, SPIKED BAR FAS CIRCON CORP. * JE5623

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other