BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 4182999 · Received October 17, 2014

    Report

    Report Number
    3006695864-2014-00460
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    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 WAS NOT ABLE TO CONFIRM OR DUPLICATE THE REPORTED ISSUE DESCRIBED BY THE ACCOUNT. THE FSS PROACTIVELY REPLACED THE ADVANTECH PRINTED CIRCUIT BOARD (PCB) AND HARD DRIVE. IN ADDITION, THE FSS PERFORMED AN ANNUAL PREVENTATIVE MAINTENANCE. THE FSS PERFORMED A FIELD SERVICE CHECKLIST. THE FSS PERFORMED A SOFTWARE UPGRADE AND PERFORMED ALL CALIBRATIONS. 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 SURGERY CENTER REPORTED THE PHACOEMULSIFICATION UNIT LOCKED UP AT THE END OF A PROCEDURE. IN ADDITION, WHEN LOADING THE CASSETTE, THERE WAS NO AUDIBLE PROMPT AND THE SYSTEM FROZE. THE SURGERY CENTER REBOOTED THE UNIT AND WAS ABLE TO PASS THE PRIME AND TUNE STAGE AND THE MONITOR WENT INTO A BLACK SCREEN. THE SURGERY CENTER WAS NOT ABLE TO COMPLETE THE PROCEDURE WITH THE SAME UNIT AND SURGEON HAD TO COMPLETE THE CATARACT SURGERY MANUALLY. THE PROCEDURE WAS COMPLETELY SUCCESSFULLY. THE SURGERY CENTER INDICATED THERE WAS A DELAY TIME BUT NO CONSEQUENCE TO THE PATIENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661558 WHITESTAR SIGNATURE SYSTEM SIGNATURE HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR