BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO BARE-TIP FIBEROPTIC

    MDR report key: 241146 · Received September 16, 1999

    Report

    Report Number
    1527736-1999-04918
    Event Type
    Malfunction
    Date Received
    September 16, 1999
    Date of Event
    August 5, 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 TISSUE ABLATION FOR INTERNAL AND EXTERNAL CONDYLOMA UTILIZING THE BARE-TIP FIBER PRODUCT LF020. HE BEGAN WITH THE EXTERNAL CONDYLOMA WITH A POWER SETTING OF 10W. 10W WAS USED FOR ALL EXTERNAL CONDYLOMA WITHOUT INCIDENCE. THE DR THEN BEGAN TISSUE ABLATION OF THE INTERNAL CONDYLOMA. HE INCREASED POWER TO 15W FOR THE DURATION OF TISSUE ABLATION OF INTERNAL CONDYLOMA. TISSUE ABLATION COMPLETED BOTH INTERNALLY AND EXTERNALLY WITHOUT INCIDENT. REPORTED FOR CONTROL PURPOSES PER REQUEST FROM INDIGO QUALITY 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