BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFLEX

    MDR report key: 7739029 · Received August 1, 2018

    Report

    Report Number
    7739029
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    June 13, 2018
    Report Date
    July 23, 2018
    Manufacturer
    INNOVAQUARTZ LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING URETEROSCOPY WITH LASER LITHOTRIPSY, SURGEON REQUESTED THE LASER FIBER BE TRIMMED. SURGEON REMOVED LASER FIBER FROM VIDEO URETEROSCOPE AND HANDED IT OFF TO THE SCRUB TECHNOLOGIST. SOMETHING BLUE WAS STILL PROTRUDING FROM THE END OF THE SCOPE INSIDE THE PATIENT. THE SURGEON REMOVED THE SCOPE FROM THE PATIENT BUT DIDN'T SEE ANYTHING BLUE AT THE END OF THE SCOPE. HE ATTEMPTED TO PASS A GUIDEWIRE DOWN THE SCOPE TO ENSURE THE CHANNEL WAS CLEAR BUT WAS UNSUCCESSFUL, THE WIRE WOULD NOT PASS. HE THEN ATTEMPTED TO PASS THE SAME WIRE UP THE SCOPE. THAT MANEUVER PUSHED SOME LASER FIBER OUT OF THE WORKING CHANNEL BUT NOT ALL THE WAY AND BOTH THE FIBER AND WIRE BECAME STUCK. SURGEON ATTEMPTED TO PULL THE FIBER FROM THE WORKING CHANNEL WITH A MOSQUITO CLAMP BUT WAS UNABLE TO GET IT OUT. THE SERVICE LINE COORDINATOR HAD BEEN CALLED TO THE ROOM, SO THE SCOPE WAS REMOVED FROM THE FIELD, GIVEN TO HER AND A NEW SCOPE WAS PROVIDED AND THE SURGEON WAS ABLE TO COMPLETE THE CASE. THE COORDINATOR TOOK THE SCOPE TO STERILE PROCESSING DEPARTMENT WHERE A PIECE OF LASER FIBER APPROXIMATELY 12 INCHES LONG WAS EXTRACTED FROM THE SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580227 PROFLEX POWERED LASER SURGICAL INSTRUMENT GEX INNOVAQUARTZ LLC 33217005

    Patients

    Seq Age Sex Outcome Treatment
    1 20805 DA