BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 4190804 · Received October 21, 2014

    Report

    Report Number
    3006695864-2014-00467
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED AS TO NO IMPACT OR NO INJURY WAS REPORTED. THE CATEGORIES FOR OUTCOMES ATTRIBUTED TO ADVERSE EVENT. THE CATEGORIES ARE NOT APPLICABLE TO THE EVENT AS IT PERTAINS TO A PRODUCT PROBLEM. THE PHACOEMULSIFICATION MACHINE WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN AMO FIELD SERVICE SPECIALIST (FSS). THE FSS ATTEMPTED TO RESOLVE THE VITRECTOMY ISSUES BY RECALIBRATING THE VITRECTOMY OPERATIONS AT INITIAL VISIT TO THE SITE LOCATION. WITHIN A WEEK, A SECOND VISIT FROM THE FSS WAS NECESSARY. THE RECALIBRATIONS OF THE VITRECTOMY OPERATIONS WERE HELPFUL FOR TEMPORARY USE. WITHIN A WEEK, THE FSS RE-EXAMINED THE VITRECTOMY OPERATIONS AND DETERMINE THE VITRECTOMY CUT VALVE ASSEMBLY REQUIRED REPLACEMENT. THE FSS PERFORMED A FIELD SERVICE CHECKLIST. THE SYSTEM WAS VERIFIED FOR ALL MODES OF OPERATIONS. THE SYSTEM MET AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED DURING A CATARACT PROCEDURE, THE VITRECTOMY CUTTER FAILED TO INITIATE. A BACK UP UNIT WAS USED TO COMPLETE THE CASE. THE CLINIC REPORTED THE PATIENT OUTCOME FINE, THEREFORE NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669751 WHITESTAR SIGNATURE SYSTEM SIGNATURE HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1