BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3000 LE LASER

    MDR report key: 2102820 · Received April 12, 2011

    Report

    Report Number
    2028159-2011-00527
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    GEX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A MEDICAL SUPERVISOR REPORTED THAT THE LASER WAS NOT PERFORMING THE LASER PULSES CORRECTLY. THERE WAS LOW POTENCY. THIS OCCURRED DURING THREE PROCEDURES. THE THREE CASES WERE CANCELLED, AND THE REPORT INDICATED THAT THERE WAS NO HARM TO THE PTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3000 LE LASER LASER INSTRUMENT, SURGICAL, POWERED GEX ALCON - IRVINE TECHNOLOGY CENTER 3000LE NA

    Patients

    Seq Age Sex Outcome Treatment
    1