BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARE-TIP FIBEROPTIC

    MDR report key: 248877 · Received November 8, 1999

    Report

    Report Number
    MW1017496
    Event Type
    Malfunction
    Date Received
    November 8, 1999
    Date of Event
    October 29, 1999
    Report Date
    October 29, 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

    PROBLEM OCCURRED DURING INDIGO LASER TREATMENT FOR URETHRAL STRICTURES. THE FIBER DIDN'T APPEAR TO WORK. NO TISSUE SEPARATION OR CHANGE TOOK PLACE THAT WAS OBVIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARE-TIP FIBEROPTIC INDIGO LASER FIBER LNK INDIGO MEDICAL, INC. LF 020 M4053W

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other