BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 4183097 · Received October 17, 2014

    Report

    Report Number
    3006695864-2014-00461
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 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

    THE CATEGORIES FOR OUTCOMES ATTRIBUTED TO ADVERSE EVENT. THE CATEGORIES ARE NOT APPLICABLE TO THE EVENT AS IT PERTAINS TO A PRODUCT PROBLEM. (B)(4). 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 TESTED SYSTEM IN THE SURGEON¿S PROGRAM WHEN THE ISSUES OCCURRED AND SYSTEM FUNCTIONED PROPERLY. IN ADDITION, THE HANDPIECE WAS TESTED AND IS WORKING AS INTENDED. 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 DURING A CATARACT PROCEDURE THE PHACOEMULSIFICATION UNIT WOULD NOT GO INTO PHACO MODE. THE SURGERY CENTER INDICATED THE HANDPIECE WOULD PASS THE PRIME AND TUNE STAGE BUT THE PHACO MODE WOULD NOT INITIATE. THE ACCOUNT ATTEMPTED TO USE ANOTHER HANDPIECE AND AGAIN THE PRIME AND TUNE STAGE WOULD PASS BUT THE PHACO WOULD NOT WORK. THE SURGERY CENTER USED A BACKUP MACHINE TO COMPLETE THE PROCEDURE. THE SURGERY CENTER SUSPECTED THE UNIT AS THE ISSUE DUE TO TWO DIFFERENT HAND PIECES USED WITH INITIAL UNIT WORKED PROPERLY WHEN USED ON THE BACK UP UNIT. THE SURGERY CENTER INDICATED THERE WAS A DELAY TIME OF FIVE TO TEN MINUTES TO BRING UP THE BACKUP UNIT. THERE WAS NO CONSEQUENCE TO THE PATIENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660625 WHITESTAR SIGNATURE SYSTEM SIGNATURE HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR HANDPIECE E218828, TUBING PACK LOT NO UNKNOWN