BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 3973729 · Received August 1, 2014

    Report

    Report Number
    3006695864-2014-00366
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHACOEMULSIFICATION MACHINE WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN AMO FIELD SERVICE SPECIALIST (FSS). THE FSS FOUND THE VITRECTOMY MODE WORKING AS INTENDED. THE FSS SUSPECTS THE SURGEON MAY HAVE INADVERTENTLY PRESSED ON THE FOOT PEDAL SIDE SWITCH DISABLING THE FOOT PEDAL. IN ADDITION, THE FSS TESTED THREE VITRECTOMY TUBING PACK ACCESSORIES. THE FSS FOUND THE VITRECTOMY ACCESSORIES WERE WORKING AS INTENDED. THE SYSTEM WAS VERIFIED FOR ALL MODES (INCLUDING VITRECTOMY MODE) OF OPERATIONS AND CALIBRATIONS. THE SYSTEM MET AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED EXPERIENCING A POSTERIOR CAPSULE TEAR RESULTING IN UNPLANNED VITRECTOMY IN THE PATIENT¿S OPERATIVE EYE DURING A CATARACT EXTRACTION PROCEDURE. THE CLINIC REPORTED AN UNSTABLE CHAMBER. A THREE-PIECE LENS WAS IMPLANTED AND PLACED IN THE SULCULUS. IN ADDITION, THE CLINIC INDICATED HAVING VITRECTOMY SET UP ISSUES CAUSING A DELAY OF FIVE TO TEN MINUTES. THE CLINIC WAS ABLE TO SUCCESSFULLY USE THE VITRECTOMY HANDPIECE TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449977 WHITESTAR SIGNATURE SYSTEM SIGNATURE HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 76 Required Intervention