BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO BARE-TIP FIBEROPTIC

    MDR report key: 241143 · Received September 16, 1999

    Report

    Report Number
    1527736-1999-04908
    Event Type
    Malfunction
    Date Received
    September 16, 1999
    Report Date
    August 6, 1999
    Manufacturer
    INDIGO MEDICAL, INC.
    Product Code
    GEX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DR PERFORMED A BLADDER NECK INCISION WITH THE BARE TIP FIBER PRODUCT WITHOUT INCIDENCE. THE DR BEGAN THE PROCEDURE WITH POWER SETTING OF 10W. HE INCREASED TO 15W TO ENHANCE TISSUE ABLATION. A FINAL INCREASE TO 20W RESULTED IN AN ERROR CODE 205, LASER NEEDS RECALIBRATION. THE MACHINE WAS RESET AND TREATMENT ATTEMPTED AGAIN. AFTER 20 SECONDS ERROR CODE 201 REGISTERED, LASER NEEDS RECALIBRATION. MACHINE RESET AND FINAL TREATMENT PERFORMED RESULTING IN ERROR CODE 204, LASER NEEDS RECALIBRATION. TREATMENT FINISHED AND THE LASER WAS RETURNED FOR CALIBRATION. REPORTED TO CONTROL PURPOSES PER REQUEST FROM INDIGO QUAILITY SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDIGO BARE-TIP FIBEROPTIC INDIGO-FIBER GEX INDIGO MEDICAL, INC. NA M4ETIX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other