BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO FIBEROPTIC TEMPERATURE SENSING FIBER

    MDR report key: 246575 · Received October 25, 1999

    Report

    Report Number
    1527736-1999-05506
    Event Type
    Malfunction
    Date Received
    October 25, 1999
    Date of Event
    October 5, 1999
    Report Date
    October 5, 1999
    Manufacturer
    INDIGO MEDICAL, INC.
    Product Code
    GEX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING AN INTERSTITIAL LASER COAGULATION. IT WAS REPORTED THE FIBER WORKED FOR THE FIRST TWO STICKS AND THEN QUIT WORKING. THE CALLER HAD NO SPECIFICS AS TO ERROR CODES OR ADD'L INFO ON WHAT WAS MEANT BY "QUIT WORKING". THE CASE WAS COMPLETED WITH 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 M4EE7H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other