BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALASE

    MDR report key: 161612 · Received March 30, 1998

    Report

    Report Number
    MW1013452
    Event Type
    Malfunction
    Date Received
    March 30, 1998
    Date of Event
    February 27, 1998
    Report Date
    March 30, 1998
    Manufacturer
    XINTEC CORP.
    Product Code
    LNK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING LASER PROSTATECTOMY, TWO LASER, FIBERS "BLEW UP" IN PT. APPARENTLY NOT CAUSING ANY INJURY, BUT A DELAY IN THE COMPLETION OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALASE FIBER-600 MICRON ANGLE DELIVERY FIBER LNK XINTEC CORP. OPTILITE *70511-01*

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other