BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITESTAR SIGNATURE

    MDR report key: 1854523 · Received September 4, 2010

    Report

    Report Number
    2020664-2010-00064
    Event Type
    Malfunction
    Date Received
    September 4, 2010
    Date of Event
    April 17, 2008
    Report Date
    April 17, 2008
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Removal / Correction Number
    Z-1702-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMO FIELD SERVICE ENGINEER EXAMINED THE EQUIPMENT AT THE CUSTOMER LOCATION AND IMPLEMENTED THE FIELD CORRECTION ADJUSTMENTS AND NEW TOLERANCES. NO OTHER ISSUES WERE REPORTED. AMO INITIATED A FIELD CORRECTION EVENT AFTER BECOMING AWARE OF A TREND IN COMPLAINTS ASSOCIATED WITH AMO VITRECTOMY CUTTER USED IN CONJUNCTION WITH THE AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM. AMO ISSUED THE FIELD CORRECTION ON 04/02/2008 TO CHANGE THE PRIMING INSTRUCTIONS FOR THE VITRECTOMY CUTTER AND TO MODIFY PRESSURE SETTINGS ON THE SIGNATURE WHITESTAR UNIT. THE REPORT OF CORRECTION WAS SUBMITTED TO THE FDA ON 04/16/2008 (REFERENCE RECALL NUMBER Z-1702-2008). SUBSEQUENTLY, AMO REVIEWED REPORTS IN WHICH THE VITRECTOMY MODE FAILED TO START IN CONJUNCTION WITH WHITESTAR SIGNATURE UNITS AFFECTED BY THIS FIELD CORRECTION, AND DETERMINED THAT THESE EVENTS MEET THE REQUIREMENTS FOR MEDICAL DEVICE REPORTING AS MALFUNCTIONS. THEREFORE, WE ARE REPORTING THIS EVENT.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT THE VITRECTOMY FUNCTION ON THE PHACO MACHINE IS NOT WORKING. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITESTAR SIGNATURE HQC AMO MANUFACTURING USA, LLC NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1