BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO FIBEROPTIC TEMPERATURE SENSING FIBER

    MDR report key: 253010 · Received December 6, 1999

    Report

    Report Number
    1527736-1999-06127
    Event Type
    Malfunction
    Date Received
    December 6, 1999
    Date of Event
    June 29, 1998
    Report Date
    June 30, 1998
    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 DURING THE INTERSTITIAL LASER COAGULATION, THE DOCTOR EXPERIENCED THE DIFFUSER FAULT ERROR DURING THE SECOND TREATMENT SITE PLACEMENT. A SECOND FIBER WAS USED TO COMPLETE THE CASE AND 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 K48R07

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN