BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE FS LASER

    MDR report key: 1743271 · Received June 24, 2010

    Report

    Report Number
    3006695864-2010-00069
    Event Type
    Malfunction
    Date Received
    June 24, 2010
    Date of Event
    May 25, 2010
    Report Date
    May 25, 2010
    Manufacturer
    AMO MANUFACTURING USA LLC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT IMPACT. EVAL: ON MAY 25, 2010 A FIELD SERVICE ENGINEER WAS DISPATCHED TO INVESTIGATE THE LASER. DURING HIS INVESTIGATION, HE COULD NOT REPEAT THE EVENT, HOWEVER, DECIDED TO REPLACE THE STEPPER CONTROLLER BOARD BASED ON THE REPORTED FAILURE. THE STEPPER CONTROLLER BOARD WAS RETURNED FOR EVALUATION AND INSTALLED INTO A MULE TEST SYSTEM WHERE THE REPORTED EVENT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE INTRALASE FS LASER WAS USED TO CREATE A CORNEAL FLAP FOR LASIK SURGERY. THE CUSTOMER REPORTED THAT THE GANTRY WOULD NOT MOVE UP AND OFF THE PATIENT AFTER THE PROCEDURE WAS COMPLETED; INSTEAD IT WENT DOWN. THE SURGEON REMOVED HIS HAND FROM THE JOYSTICK, DROPPED THE CHAIR, WHILE THE ASSISTANT DROPPED THE CHAIR PILLOW. ALTHOUGH THERE WERE NO PATIENT INJURIES, THIS EVENT COULD HAVE LED TO A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS LASER HNO AMO MANUFACTURING USA LLC 20003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other