BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO FIBEROPTIC TEMPERATURE SENSING FIBER

    MDR report key: 253017 · Received December 6, 1999

    Report

    Report Number
    1527736-1999-06126
    Event Type
    Malfunction
    Date Received
    December 6, 1999
    Date of Event
    November 3, 1999
    Report Date
    November 3, 1999
    Manufacturer
    INDIGO MEDICAL, INC.
    Product Code
    GEX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE (1) LF001 WAS USED DURING AN "ILC" PROCEDURE. IT WAS REPORTED THAT THE TISSUE "ADAPTOVE" FIBERS WERE BEING USED AND THE LASER READ "DIFFUSER FAULT" AFTER THE FIRST FIVE SECONDS. THE PT WAS UNAFFECTED. THE CASE WAS COMPLETED WITH ANOTHER FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDIGO FIBEROPTIC TEMPERATURE SENSING FIBER INDIGO-FIBER GEX INDIGO MEDICAL, INC. NA M4EG8J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other