BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1CM TEMP-SENSING DIFFUSER TIP FIBEROPTIC

    MDR report key: 229753 · Received June 19, 1999

    Report

    Report Number
    229753
    Event Type
    Malfunction
    Date Received
    June 19, 1999
    Date of Event
    June 15, 1999
    Report Date
    June 16, 1999
    Manufacturer
    INDIGO MEDICAL INC.
    Product Code
    LNK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DR WAS PERFORMING AN INDIGO LASER TREATMENT OF THE PROSTATE. DURING THE 7TH SITE, THE LASER INDICATED THAT THE FIBER HAD A "BLACK BODY." STAFF ATTEMPTED TO WIPE THE CONNECTOR OFF WITH A SOFT CLOTH AND ATTEMPTED TO USE IT AGAIN, BUT THE SAME SIGNAL CAME UP. STAFF OPENED ANOTHER FIBER AND COMPLETED THE PROCEDURE. THERE WERE NO ADVERSE EVENTS REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1CM TEMP-SENSING DIFFUSER TIP FIBEROPTIC LASER FIBER LNK INDIGO MEDICAL INC. LF001 M4E08E

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Other