BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAR

    MDR report key: 5760231 · Received June 29, 2016

    Report

    Report Number
    3006695864-2016-00652
    Event Type
    Malfunction
    Date Received
    June 29, 2016
    Date of Event
    June 3, 2016
    Report Date
    June 29, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE SPECIALIST (FSS) VISITED SITE TO INSPECT THE UNIT. FSS FOUND JOYSTICK DAMAGED SPINNING NOT CATCHING AND HOUSING WAS CRACKED. FSS REPLACED JOYSTICK ASSEMBLY, CALIBRATED AND ALIGNED THE NEW JOYSTICK. FSS ALIGNED OPTICAL SYSTEM INCLUDING LASER CAMERAS, ADJUSTED INTEGRATOR ASSEMBLY FOR PROPER FLAT SETTING, CALIBRATED PATIENT ENERGY DETECTOR AND CLEANED MIRROR DUE TO BALANCED SALT SOLUTION (BSS) ON MIRROR. FSS VERIFIED THAT THE SYSTEM IS OPERATING PROPERLY. THE UNIT WAS FOUND TO MEET AMO SPECIFICATIONS. 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. THIS REPORT PERTAINS TO THE FIRST CASE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE SECOND CASE WHICH WAS COMPLETED ON THE SAME DAY. THE THIRD ABORTED CASE WILL BE CAPTURED IN A SEPARATE MDR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412177 STAR VISX EXCIMER LZS ABBOTT MEDICAL OPTICS 0030-2450

    Patients

    Seq Age Sex Outcome Treatment
    1