BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO FIBEROPTIC TEMPERATURE SENSING FIBER

    MDR report key: 245538 · Received October 19, 1999

    Report

    Report Number
    1527736-1999-05382
    Event Type
    Malfunction
    Date Received
    October 19, 1999
    Date of Event
    August 13, 1999
    Report Date
    August 13, 1999
    Manufacturer
    INDIGO MEDICAL, INC.
    Product Code
    GEX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) DEVICE WAS USED DURING A INTERSTITIAL LASER COAGULATION. IT WAS REPORTED BY THE AFFILIATE THAT THE LF001 DIFFUSER TIP DISLODGED AFTER THE PROTECTIVE CAP ON THE TIP WAS REMOVED. ANOTHER FIBER WAS USED TO COMPLETE THE CASE. 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 M4E906

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other