BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO FIBEROPTIC TEMPERATURE SENSING FIBER

    MDR report key: 250991 · Received November 19, 1999

    Report

    Report Number
    1527736-1999-05886
    Event Type
    Malfunction
    Date Received
    November 19, 1999
    Date of Event
    September 24, 1999
    Report Date
    September 24, 1999
    Manufacturer
    INDIGO MEDICAL, INC.
    Product Code
    GEX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) DEVICE WAS USED DURING AN INDIGO INTERSTITIAL LASER COAGULATION. IT WAS REPORTED BY THE REP THAT AFTER PUNCTURING THE GLAND FOR THE 2ND TREATMENT SITE, THE SURGEON RECEIVED A DIFFUSER FAULT ERROR. AFTER (4) SECONDS INTO THE TREATMENT, THE FAULT WAS NOTED. THE SURGEON REMOVED THE FIBER AND VIEWED THE DIFFUSER AND NOTED THAT FIBER HAD BEEN FRACTURED. THE CASE WAS COMPLETED USING ANOTHER FIBER. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDIGO FIBEROPTIC TEMPERATURE SENSING FIBER INDIGO-FIBER GEX INDIGO MEDICAL, INC. NA M4E292

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other