BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE

    MDR report key: 7457909 · Received April 25, 2018

    Report

    Report Number
    7457909
    Event Type
    Malfunction
    Date Received
    April 25, 2018
    Date of Event
    March 19, 2018
    Report Date
    April 10, 2018
    Manufacturer
    W AND R INVESTMENTS DBA LASER ENGINEERING
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CATHETER WAS INSERTED ALL OVER THE PROLENE SUTURE. THE WAVE GUIDE WAS INSERTED THROUGH THE CATHETER AFTER PURGING THE CATHETER WITH SALINE AND SUBSEQUENTLY AIR. THERE WAS A RATHER SHARP TURN IN THE POSTERIOR MIDLINE AS A FISTULA MADE A SHARP TURN THROUGH THE MUSCLE TO EXIT OUT THE INTERNAL OPENING. THIS MADE MAKING THE CURVE SOMEWHAT DIFFICULT. WE ACTUALLY HAD TO DRAG CATHETER WITH THE LASER INSIDE OF IT THROUGH ALL THE WAY UNTIL THE LASER HAD MADE IT PAST THAT AREA. THE LASER WAS THEN PASSED BEYOND THE CATHETER ITSELF. WE THEN EXCHANGED THE ANAL RETRACTORS FOR THE LASER APPROPRIATE ANAL RETRACTORS. UNFORTUNATELY WITH THE WAY THAT THE FISTULA WAS ANGLED AS WELL AS THE FACT THAT THIS OPENING OF THE RETRACTOR PLACED EXCESSIVE STRESS ON THE WAVE GUIDE. THE WAVE GUIDE ITSELF WAS NOTED TO HAVE FRACTURED DISTALLY. THE WHOLE SYSTEM WAS REMOVED AND A SECOND CATHETER WAS PLACED THROUGH THE TRACT WITH ANOTHER WAVE GUIDE THIS TIME WITHOUT THE RETRACTOR IN PLACE TO AVOID ANY UNDUE STRESS ON THE WAVE GUIDE. THE WAVEGUIDE WAS NEVER HOOKED UP TO THE LASER OR FIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305147 ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE POWERED LASER SURGICAL INSTRUMENT GEX W AND R INVESTMENTS DBA LASER ENGINEERING HWG500-2.0-3.0 102693

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR