BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1CM, TEMPERATURE-SENSING DIFUSER-TIP

    MDR report key: 248862 · Received November 8, 1999

    Report

    Report Number
    MW1017497
    Event Type
    Malfunction
    Date Received
    November 8, 1999
    Date of Event
    October 26, 1999
    Report Date
    November 4, 1999
    Manufacturer
    INDIGO MEDICAL, INC.
    Product Code
    LNK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRODUCT PROBLEM OCCURRED DURING AN INDIGO LASER OF THE PROSTATE PROCEDURE. FIRST FIBER FAILURE. WARNING ON LASER SCREEN SHOWED BLACK BODY. ANOTHER FIBER WAS OPENED, IT FAILED ALSO. SECOND FIBER'S WARNING SHOWED FIBER FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1CM, TEMPERATURE-SENSING DIFUSER-TIP LASER FIBER LNK INDIGO MEDICAL, INC. LF 001 M4E08E

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other