BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO BARE-TIP FIBEROPTIC

    MDR report key: 240973 · Received September 16, 1999

    Report

    Report Number
    1527736-1999-04936
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE UROLOGY PROCEDURE, BY THE REP THAT THE SURGEON ATTEMPTED TO USE THE INDIGO BARE TIP FIBER TO REMOVE SEVERAL BLADDER TUMORS, EVEN AFTER THE REP STATED THE FIBER WAS NOT INDICATED FOR LARGE TUMOR REMOVAL. THE SURGEON ACTIVATED THE LASER 3-4 TIMES BEFORE REALIZING THERE WERE MANY TUMORS FOR THE FIBER TO EXTRACT AND REMOVE. THE SURGEON THEN UTILIZED THE VAPORTRODE, BUT AGAIN IT WAS DIFFICULT TO REMOVE THE TUMORS, SO THE CASE WAS ABORTED. 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