BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 5760325 · Received June 29, 2016

    Report

    Report Number
    3006695864-2016-00654
    Event Type
    Injury
    Date Received
    June 29, 2016
    Date of Event
    June 3, 2016
    Report Date
    June 30, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI #: (B)(4). THE LASER MACHINE WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN ABBOTT FIELD SERVICE SPECIALIST (FSS). THE FSS FOUND JOYSTICK DAMAGED SPINNING NOT CATCHING AND HOUSING WAS CRACKED. THE FSS REPLACED THE JOYSTICK ASSEMBLY. THE JOYSTICK REPLACEMENT WAS CALIBRATED AND ALIGNED. IN ADDITION, THE FSS ALIGNED THE OPTICAL SYSTEM INCLUDING LASER CAMERAS. THE INTEGRATOR ASSEMBLY WAS ADJUSTED FOR PROPER FLAT SETTINGS; THE PATIENT ENERGY DETECTOR WAS CALIBRATED. THE FSS NOTED BALANCED SALT SOLUTION ON THE MIRROR. THE MIRROR WAS CLEANED. THE FIELD SERVICE SPECIALIST (FSS) PERFORMED A CHECKLIST AND VERIFIED ALL MODES OF OPERATIONS. THE UNIT MEETS AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED UNCONTROLLED CHAIR MOVEMENT WHILE LASER FIRING WITH THE EXCIMER LASER ON THE LAST THREE CASES OF THE DAY. THE RIGHT AND LEFT BUTTONS FOR EYE SELECTIONS ON THE PATIENT CHAIR DID NOT WORK AND THE CHAIR HAD UNCONTROLLED CHAIR MOVEMENT WHILE LASER WAS FIRING. A DESCRIPTION FROM THE ACCOUNT INDICATED THE JOYSTICK WAS DAMAGED, THEREFORE, CAUSING THE BUTTONS ON THE CHAIR TO BE DISABLED. THE DOCTOR WAS ABLE TO MOVE THE CHAIR WITH THE JOYSTICK BY HOLDING ONTO THE JOYSTICK IN PLACE OR RANGE WHILE LASER WAS FIRING. IT WAS REPORTED THAT THE LASER NEVER STOPPED FIRING WHILE THE SURGEON HELD ONTO THE JOYSTICK. TWO OF THE THREE CASES WERE COMPLETED. THE PROCEDURE THAT WAS NOT COMPLETED WAS DUE TO THE JOYSTICK STOPPED MOVING ALL TOGETHER AND HE WAS NOT ABLE TO COMPLETE THE SURGERY AND THE PROCEDURE WAS RESCHEDULED. NO PATIENT INJURY REPORTED. THIS REPORTS IS FOR THE PROCEDURE THAT WAS NOT COMPLETED AND RESCHEDULED. A SEPARATE REPORT IS BEING FILED ON EACH OF THE TWO REPORTED CASES THAT WERE COMPLETED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414762 STAR EXCIMER LASER LZS ABBOTT MEDICAL OPTICS 0030-2450

    Patients

    Seq Age Sex Outcome Treatment
    1