BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 4260273 · Received November 18, 2014

    Report

    Report Number
    3006695864-2014-00516
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 24, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IN SECTION F PROVIDED BY THE MANUFACTURER. THE CATEGORIES FOR OUTCOMES ATTRIBUTED TO ADVERSE EVENT. THE CATEGORIES ARE NOT APPLICABLE TO THE EVENT AS IT PERTAINS TO A PRODUCT PROBLEM. PHACOEMULSIFICATION MACHINE WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN AMO FIELD SERVICE SPECIALIST (FSS) AT THREE DIFFERENT SITE VISITS. DURING THE FIRST INSPECTION OF THE UNIT, THE FSS WAS NOT ABLE TO DUPLICATE OR CONFIRM THE REPORTED ISSUE OF THE UNIT FREEZING UP. THE FSE INDICATED CONTACT WASHING OF THE CONNECTOR AND THE CONNECTION WAS CHECKED AND TESTED. THE FSS PERFORMED A FIELD SERVICE CHECKLIST. THE FSS PERFORMED ALL CALIBRATIONS. THE SYSTEM WAS VERIFIED FOR ALL MODES OF OPERATIONS. THE SYSTEM MET AMO SPECIFICATIONS. DURING THE SECOND FIELD VISIT, THE FSS WAS NOT ABLE TO DUPLICATE OR CONFIRM REPORTED ISSUE. AS A PROACTIVE MEASURE, THE FSE REPLACED THE ETHERNET CABLE ASSEMBLY, THE SUBSYSTEM CONTROLLER PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), THE GRAPHICAL USER INTERFACE (GUI), AND THE POWER SUPPLY. IN ADDITION, AS PART OF THE FIELD SERVICE CHECKLIST, THE FSS FOUND THE REMOTE CONTROL NOT PAIRING AND POWER SWITCH LOOSE. THE FSS REPLACED THE REMOTE CONTROL PCBA AND POWER SWITCH. THE REMOTE PCBA AND SWITCH WAS NOT RELATED TO THE ISSUE REPORTED. THE SYSTEM WAS VERIFIED FOR ALL MODES OF OPERATIONS AND MET AMO SPECIFICATIONS. ON THE THIRD FIELD SERVICE SITE VISIT, THE FSS WAS NOT ABLE TO CONFIRM OR UNABLE TO DUPLICATE THE REPORTED ISSUE. THE FSS VERIFIED ALL MODES OF OPERATIONS AND THE SYSTEM MET AMO SPECIFICATIONS. TO SATISFY THE ACCOUNT, THE UNIT WAS DE-INSTALLED AND A REPLACED. 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 PHACOEMULSIFICATION UNIT SHUTS OFF DURING SURGICAL PROCEDURE AND CANNOT BE RESTARTED IN THE SAME PROCEDURE. A BACK UP UNIT WAS USED TO COMPLETE THE CASE. THERE WAS A DELAY OF 10 MINUTES TO BRING UP THE BACKUP UNIT. THERE WAS NO CONSEQUENCE TO THE PATIENT. NO PATIENT INJURY REPORTED. THIS IS ONE OF THREE REPORTS OF UNIT SHUTTING DOWN DURING USE ON THREE DIFFERENT INCIDENT DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746597 WHITESTAR SIGNATURE SYSTEM SIGNATURE HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR