BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUREPOINT

    MDR report key: 1912453 · Received November 2, 2010

    Report

    Report Number
    2028159-2010-02131
    Event Type
    Other
    Date Received
    November 2, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQF
    PMA / PMN Number
    K062624
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A SYSTEM MESSAGE WAS DISPLAYED AND THE LASER STOPPED DURING A PROCEDURE. THREE ATTEMPTS WERE MADE TO REBOOT THE SYSTEM WITHOUT SUCCESS. THE CUSTOMER THEN CALLED TECHNICAL SUPPORT SERVICES (TSS) AND WAS TOLD THE SYSTEM WOULD REQUIRE SERVICE BEFORE IT COULD BE USED AGAIN. THE CUSTOMER TRIED TO OBTAIN ANOTHER LASER TO COMPLETE THE PROCEDURE AND WAS UNABLE, THEN ATTEMPTED TO TRY THE SYSTEM ONCE AGAIN. THE SYSTEM REBOOTED SUCCESSFULLY AND THE CASE WAS COMPLETED WITHOUT ANY FURTHER INCIDENTS. THERE WAS NO PT HARM REPORTED, HOWEVER, THERE WAS A DELAY OF 45-60 MINUTES RESULTING IN THE PT BEING UNDER GENERAL ANESTHESIA LONGER THAN PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUREPOINT LASER, OPHTHALMIC HQF ALCON - IRVINE TECHNOLOGY CENTER PUREPOINT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Other