BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILITE SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 2010561 · Received March 1, 2011

    Report

    Report Number
    1825146-2011-00016
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    February 4, 2011
    Report Date
    March 1, 2011
    Manufacturer
    COOK UROLOGICAL INC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE HAS NOT BEEN RECEIVED FOR EVAL, THE FACILITY HAS BEEN CONTACTED TO INQUIRE WHEN THE PRODUCT WILL BE RETURNED. AS STATED IN THE CUSTOMER STATEMENT, NO HARM TO THE PT OCCURRED HOWEVER, A 2.5CM SEGMENT OF THE FIBER WAS RETRIEVED FROM INSIDE THE PT USING A URETERAL STONE BASKET. DUE TO THE ISSUE WITH THE FIBER, THE PT WILL HAVE TO RETURN AT A LATER DATE TO HAVE THE REMAINDER OF THE STONES FRAGMENTED. AS INFO BECOMES AVAILABLE IT WILL BE FORWARDED.

    Description of Event or Problem · 1

    THE SURGEON (DR (B)(6)) WAS VAPORIZING A STONE (USING URETERORENOSCOPE P5 FROM OLYMPUS) WITH A NORMAL DEFLEXION (AROUND 45-50 DEGREES), USING ONE OF OUR SINGLE USE LASER FIBERS 273 MICRONS ((B)(4), SERIAL NUMBER (B)(4)). LASER ODYSSEY-30 WAS USED FOR THIS PROCEDURE WITH A 5 HZ AND 1.5 JOULES (=7.5 WATTS). AFTER 30 MINUTES OF VAPORIZATION, SURGEON WAS CLOSE TO FINISH IT, SUDDENLY, WE HAVE SEEN A BIG LIGHT ON THE SCREEN AND A CLEAR DAMAGE APPEARED ON THE RIGHT SIDE OF THE SCREEN. WE'VE PUT THE LASER ON STANDBY AND THE SURGEON REMOVED THE LASER FIBER FROM THE URETEROSCOPE. WE'VE SEEN THAT THE LASER FIBER HAS BROKEN INSIDE THE URETEROSCOPE BECAUSE A PIECE OF APPROXIMATIVELY 2,5 CMS WAS STILL IN THE PT. HE REMOVED ALSO THIS PIECE (LASER FIBER EXTREMITY) WITH AN N-GAGE. THE PT WILL HAVE TO DO AN ADDITIONAL FLEXIBLE URETEROSCOPY TO REFRAGMENT THE STONES WITH A LASER WHICH HAS NOT BEEN FINISHED DURING THE FIRST OPERATION. THERE WERE NO ADVERSE EFFECTS ON THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTILITE SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK UROLOGICAL INC NA U1799963

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention