BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO FIBEROPTIC TEMPERATURE SENSING FIBER

    MDR report key: 245543 · Received October 19, 1999

    Report

    Report Number
    1527736-1999-05388
    Event Type
    Malfunction
    Date Received
    October 19, 1999
    Date of Event
    September 27, 1999
    Report Date
    September 27, 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 BY THE REP THAT THE (2) LFOO1 WERE USED DURING AN INTERSTITIAL LASER COAGULATION PROCEDURE. IT WAS REPORTED THAT THE DIFFUSER FAULT CAME UP ON THE FIBER IN THE FIRST PUNCTURE SITE. THE SALES REP DID NOT NOTICE AN IMPROPER TECHNIQUE. A SECOND FIBER WAS USED AND RECEIVED A DIFFUSER FAULT ON THE THIRD STICK. 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 M4E082

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other