BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 3920280 · Received July 8, 2014

    Report

    Report Number
    2020664-2014-00052
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 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

    THE SUBSYSTEM CONTROLLER BOARD (SSC) ASSEMBLY WAS REPLACED AND RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATIONS. THE RETURNED SSC WAS VISUALLY VERIFIED AND CONFIRMED THAT CAPACITORS(C) C120 AND C243 WERE BADLY DAMAGED ON THIS BOARD, NO FUNCTIONAL TEST WAS PERFORMED. THE PART WAS SCRAPPED BY DEPOT. NO DEFINITIVE CAUSE FOR THE FAILURE WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE MANUFACTURER REPORT NUMBER SHOULD HAVE BEEN 3006695864. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. THE PHACOEMULSIFICATION MACHINE WAS EXAMINED AND TESTED BY AN AMO FIELD SERVICE SPECIALIST (FSS) AT THE CUSTOMER'S LOCATION. DURING INSPECTION OF THE UNIT, THE FSS FOUND EVIDENCE OF CHARRED COMPONENTS ON THE SUBSYSTEM CONTROLLER BOARD. THE FSS REPLACED THE SUBSYSTEM CONTROLLER BOARD. NO PATIENT INJURY WAS REPORTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    AN AMO REPRESENTATIVE REPORTED THAT PRIOR TO START OF A CATARACT PROCEDURE, THE UNIT DISPLAYED A 284 ¿PHACO POWER SUPPLY ERROR; THE IV POLE DESCENDED TO THE LOWEST HEIGHT AND THE UNIT EJECTED THE TUBING CASSETTE. THE CLINIC REPORTED A BURNING ODOR AND OBSERVED A WHITE SMOKE FROM BEHIND THE MACHINE. ALTHOUGH THE EVENT OCCURRED AT SET UP AND PROCEDURE HAD NOT COMMENCED, THERE WAS AN APPROXIMATELY ONE HOUR DELAY. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398157 WHITESTAR SIGNATURE SYSTEM SIGNATURE HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other