BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADD FIBER

    MDR report key: 11639 · Received February 18, 1994

    Report

    Report Number
    MW1000822
    Event Type
    Other
    Date Received
    February 18, 1994
    Manufacturer
    LASERSCOPE
    Product Code
    LNK
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE DOING CYSTOSCOPY LASER PROSTATECTOMY AT END OF PROCEDURE, THE LASER FIBER TIP BURNED AWAY AND APPARENTLY BROKE IN TWO. THE TIP WAS NOT RETRIEVED. A SUCTION WAS ATTACHED TO THE CYSTOSCOPE AT THE TIME. THE TIP MAY HAVE BEEN SUCTIONED OUT OF THE BLADDER. AS IS ROUTINE, A CATHETER WAS LEFT IN PLACE POST-OPERATIVELY. CO WAS NOTIFIED AND THE FIBER WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADD FIBER LNK LASERSCOPE 930512

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other