BEUDAMED
    FDA Adverse Event Summary report: N

    WHITESTAR SIGNATURE¿ SYSTEM

    MDR report key: 2904888 · Received January 9, 2013

    Report

    Report Number
    2020664-2013-00002
    Date Received
    January 9, 2013
    Report Date
    December 11, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE WAS ON SITE TO ADDRESS REPORT OF SYSTEM FREEZING WHEN SWITCHING FROM DIATHERMY MODE TO PHACO MODE. ERROR/EVENT LOG INDICATED TWO INSTANCES OF TIMEOUT ERRORS (2011 AND 2012) OCCURRING TOGETHER. LOG INDICATED A NUMBER OF 416 ERRORS (FOOTPEDAL NOT CONNECTED), REGIONAL TECHNICAL SUPPORT ENGINEER SURMISES IT MAY BE DUE TO FOOTPEDAL NOT BEING REMOVED AND WOKE PRIOR TO STARTING THE PHACOEMULSIFICATION UNIT. EXPLAINED TO STAFF THE STEPS OF UNCRADLE (THE FOOTPEDAL), WAKE AND THEN TURN UNIT ''ON''. REPLACED SINGLE LEAD ACIC (SLA BATTERY) AND PERFORMED SYSTEM UPGRADE AS PER TECHNICAL SERVICE BULLETINS WHICH INCLUDES REPLACEMENT OF PRINTED CIRCUIT BOARDS ASSEMBLIES. SYSTEM MEETS ALL ABBOTT MEDICAL OPTICS SPECIFICATIONS. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    TYPE OF REPORTABLE EVENT: SERIOUS INJURY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT SYSTEM FROZE WHEN SWITCHING FROM DIATHERMY MODE TO PHACO MODE. THERE WAS A PATIENT DELAY OF 10-15 MINS WHILE THE BACK-UP SYSTEM WAS SET UP. THEY ALSO REPORTED THAT THERE WAS NO PATIENT INJURY AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12141 WHITESTAR SIGNATURE¿ SYSTEM SIGNATURE HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other