BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 4738589 · Received April 29, 2015

    Report

    Report Number
    3006695864-2015-00173
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    March 24, 2015
    Report Date
    September 25, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT AGE AND GENDER: PATIENT INFORMATION IS UNKNOWN AS IT WAS NOT PROVIDED AND NO KNOWN CONSEQUENCE TO PATIENT. THE PHACOEMULSIFICATION MACHINE WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN AMO FIELD SERVICE SPECIALIST (FSS). THE FIELD SERVICE SPECIALIST REPLACED THE ADVANTECH BOARD, NETWORK ADAPTER, INSTRUMENT MANAGER, STACK THRU CONTACT CONNECTOR, AND SUBSYSTEM CONTROLLER BOARD. WHILE THE FSS ON SITE, A PREVENTATIVE MAINTENANCE WAS PERFORMED. AS PART OF THE PREVENTATIVE MAINTENANCE, THE FILTERS WERE REPLACED. THE FSS PERFORMED A FIELD SERVICE CHECKLIST. THE SYSTEM WAS VERIFIED FOR ALL MODES OF OPERATIONS. THE SYSTEM MET AMO SPECIFICATIONS. ALTHOUGH THE UNIT WAS REPAIRED, A DECISION WAS MADE TO REPLACE THE PHACOEMULSIFICATION UNIT AS REQUESTED BY THE SURGERY CENTER. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED THE PHACOEMULSIFICATION UNIT DISPLAYED A 2012-IH TIMEOUT ERROR AND A SAFE MODE STATE. THE ISSUES OCCURRED ON (B)(6) 2015. THE SURGERY CENTER INDICATED DURING A CATARACT EXTRACTION PROCEDURE, THE PHACOEMULSIFICATION UNIT STOPPED AND DISPLAYED A SAFE MODE ERROR MESSAGE. THE SURGEON HAD TO STOP THE SURGERY AND RESTART THE UNIT WHILE THE PATIENT¿S EYE WAS OPEN. ALL SCHEDULED SURGERIES WERE POSTPONED THE DAY OF EVENT. A WEEK LATER, THE SURGERY CENTER REPORTED THE UNIT HAD ISSUES OCCURRING AGAIN ON THREE OCCASIONS ON THE SAME DAY. THE SURGEON HAD TO CANCEL PART OF HIS SURGERY DAILY PROGRAM. ONE OF THE THREE ISSUES OCCURRED DURING A MONOPHTHALMIC SURGERY. ALTHOUGH THE PROCEDURE WAS COMPLETED, THERE WAS A 30 MINUTE DELAY TO FINISH THE PROCEDURE. THE SURGERY CENTER REQUESTED THE PHACOEMULSIFICATION UNIT BE REPLACED DUE TO THE CONTINUOUS ISSUES REPORTED. THE REPORTED EVENT IS A PRODUCT PROBLEM AND THERE IS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282825 WHITESTAR SIGNATURE SYSTEM SIGNATURE HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1