BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMR HOLMIUM LASER SYSTEM

    MDR report key: 268553 · Received March 10, 2000

    Report

    Report Number
    2950727-2000-00001
    Event Type
    Injury
    Date Received
    March 10, 2000
    Date of Event
    October 21, 1999
    Report Date
    March 7, 2000
    Manufacturer
    ECLIPSE SURGICAL TECHNOLOGIES
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE CREATION OF TMR CHANNELS, THE TIP OF THE FIBER BURNED AND BROKE OFF FROM THE HANDPIECE. THE TIP OF THE FIBER WHICH SEPARATED FROM THE HANDPIECE ODGED IN THE PT'S MYOCARDIUM. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP OF THE FIBER FROM THE MYOCARDIUM WITHOUT CONSEQUENCE.

    Description of Event or Problem · 1

    DURING THE CREATION OF TMR CHANNELS, THE TIP OF THE FIBER BURNED AND BROKE OFF FROM THE HANDPIECE. THE TIP OF THE FIBER WHICH SEPARATED FROM THE HANDPIECE LODGED IN THE PT'S MYOCARDIUM. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP OF THE FIBER FROM THE MYOCARDIUM WITHOUT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMR HOLMIUM LASER SYSTEM HOLMIUM LASER, HANDPIECE & FIBEROPTIC DELIVERY SYSTEM GEX ECLIPSE SURGICAL TECHNOLOGIES TMR 2000; SOLOGRIP II NONE; TA-02336

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention