BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 1620804 · Received March 1, 2010

    Report

    Report Number
    3003288808-2010-00161
    Event Type
    Injury
    Date Received
    March 1, 2010
    Date of Event
    January 28, 2010
    Report Date
    January 28, 2010
    Manufacturer
    WAVELIGHT AG (PRESSATH)
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DETERMINATION OF ROOT CAUSE: ASSESSMENT: DURING THE ONSITE INVESTIGATION, THE TERRITORY MANAGER (TM) NOTED THAT THE BED WOULD NOT MOVE IN THE Y DIRECTION EITHER BY AUTO-LOAD SWITCH OR BY THE JOYSTICK. THE TM NOTICED THE POWER CABLE BETWEEN THE AFT Y LIMIT SWITCHES WAS OUT OF PLACE AND WAS BLOCKING THE BED'S LIMIT SWITCHES. TO ADDRESS THIS ISSUE, THE TM REMOVED THE CABLE AND TIE-WRAPPED THE EXCESS CABLE, THEN VERIFIED THAT THE BED WORKED IN ALL DIRECTIONS. THE TM COMPLETED A SUCCESSFUL SYSTEM VERIFICATION TO SPECIFICATIONS. CONCLUSION: BASED ON THE RESULT OF THE INVESTIGATION, THE ROOT CAUSE OF THE EVENT WAS THE AFT Y LIMIT SWITCHES WERE OUT OF PLACE AND WAS BLOCKING THE BED'S LIMIT SWITCHES. (B) (4)

    Description of Event or Problem · 1

    ADVERSE EVENT: INTERRUPTED PROCEDURE. MALFUNCTION: BED CONTROL FAILED. AN OPHTHALMIC TECHNICIAN REPORTED A PT WAS MOVED TO ANOTHER LASER PLATFORM AFTER A FLAP HAS BEEN MADE DURING REFRACTIVE SURGERY. SHE STATED THE INITIAL LASER BED WOULD NOT MOVE IN THE Y-DIRECTION. SHE REPORTED THE SURGERY WAS COMPLETED WITHOUT ANY ISSUES. THE OPHTHALMIC TECHNICIAN STATED THE OUTCOME OF THE PT IS AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT AG (PRESSATH) 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention