BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITESTAR SIGNATURE

    MDR report key: 2261610 · Received September 19, 2011

    Report

    Report Number
    2020664-2011-00075
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 25, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    PMA / PMN Number
    K981116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN AMO AUTHORIZED FIELD SERVICE ENGINEER EXAMINED THE PHACO SYSTEM AT THE CUSTOMER'S LOCATION AND WAS NOT ABLE TO REPRODUCE THE REPORTED ISSUE. THE CUSTOMER HAS REPORTED THAT NO FURTHER EPISODES HAVE OCCURRED. ALL PERTINENT INFO AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFO THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VITRECTOMY FUNCTION FAILED TO START ON THE PHACOEMULSIFICATION MACHINE. THE CUSTOMER WAS ABLE TO REBOOT THE MACHINE AND THE VITRECTOMY FUNCTION STARTED UP WHICH ALLOWED THE PROCEDURE TO BE COMPLETED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITESTAR SIGNATURE HQC AMO MANUFACTURING USA, LLC NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1