BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 2428563 · Received January 20, 2012

    Report

    Report Number
    3008772169-2012-00003
    Event Type
    Injury
    Date Received
    January 20, 2012
    Date of Event
    December 21, 2011
    Report Date
    December 21, 2011
    Manufacturer
    ALCON - LENSX LASERS, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE LOOSE CABLE CONNECTION COULD NOT BE DETERMINED. IN-HOUSE TESTING WAS PERFORMED TO ATTEMPT TO SIMULATE THIS CONDITION; ABLE TO REPRODUCE FAILURE MODE. THE EVENT IS BELIEVED TO BE AN ISOLATED ISSUE LIMITED TO THIS SYSTEM AND NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THE DEVICE WAS REPAIRED AND CONFIRMED TO BE WITHIN SPECIFICATION AND THERE HAVE BEEN NO FURTHER ISSUES REPORTED. (B)(4).

    Description of Event or Problem · 1

    A COMPANY SERVICE REPRESENTATIVE WAS ONSITE WHEN THE SYSTEM GENERATED VIDEO MICROSCOPE OCT ERRORS. NO PT INVOLVED. WHILE THE DEVICE WAS BEING SERVICED, THE ENGINEER WAS RUNNING TEST TREATMENTS AND NOTED ON TWO OCCASIONS, A SITUATION WHERE THE GANTRY WOULD CONTINUE TO MOVE IN THE DOWNWARD DIRECTION AFTER RELEASE OF THE JOYSTICK. IN THE FIRST INSTANCE, ROTATING THE JOYSTICK TO MOVE THE GANTRY IN THE UPWARD DIRECTION CAUSED THE GANTRY TO STOP. IN THE SECOND INSTANCE, THE ENGINEER ALLOWED THE GANTRY TO CONTINUE MOVING WHILE ATTEMPTING TO ASCERTAIN IF THE EYE CONTACT AND END OF TRAVEL APPLANATION INDICATORS WOULD AFFECT MOVEMENT. THE GANTRY CONTINUED TO MOVE DOWN PAST THE LOWER LIMIT SWITCH AND RUN INTO THE MECHANICAL HARD STOP. UPON FURTHER INVESTIGATION, THE ENGINEER FOUND THAT THE SIGNAL INTERFACE CABLE TO THE Z GANTRY MOTOR WAS NOT FULLY SEATED. THE CONNECTOR WAS RESEATED AND OVER THE COURSE OF THE NEXT TWO DAYS, WHILE ADDRESSING THE ORIGINAL REASON FOR THE SERVICE VISIT (VM/OCT ERRORS), THE GANTRY WAS TESTED EXTENSIVELY AND NO FURTHER OCCURRENCE OF THE UNINTENDED DOWNWARD GANTRY MOTION WAS OBSERVED. THE ENGINEER BROUGHT THE ISSUE TO THE SURGEON'S ATTENTION AND THE SURGEON RESPONDED THAT HE HAD PREVIOUSLY EXPERIENCED A SIMILAR ISSUE WITH TWO PATIENTS, WHERE THE GANTRY WAS MOVING DOWNWARD AFTER RELEASE OF THE JOYSTICK, BUT HE WAS ABLE TO TURN THE JOYSTICK IN THE UPWARDS DIRECTION AND THE GANTRY STOPPED WITHOUT CONTACTING THE PT. NO PT INJURY RESULTED. THE DATES OF THE SURGEON-REPORTED EVENTS WERE NOT KNOWN AND NO PT IDENTIFIERS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention