BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPHTHALAS 532 EYELITE LASER SYSTEM

    MDR report key: 2214146 · Received July 22, 2011

    Report

    Report Number
    2028159-2011-00854
    Event Type
    Other
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    GEX
    PMA / PMN Number
    K914434
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE TECHNICAL SUPPORT SPECIALIST (TSS) TO ASSIST WITH TROUBLESHOOTING. THE CUSTOMER NOTED THE SURGEON MOVED THE POWER FROM 100-799 TOO QUICKLY AND THE SYSTEM DISPLAYED A SYSTEM MESSAGE. THE TSS ADVISED THE CUSTOMER TO REBOOT THE SYSTEM AND MOVE THE POWER UP SLOWLY. THE FACILITY DID NOT REQUEST SERVICE. NO SAMPLES WERE RETURNED FOR EVAL. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A SYSTEM MESSAGE WAS DISPLAYED DURING SURGERY. THE PT AND SURGEON WENT TO ANOTHER SURGERY CENTER IN ORDER TO FINISH THE PROCEDURE. THERE WAS 10 MIN DELAY REPORTED. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPHTHALAS 532 EYELITE LASER SYSTEM LASER INSTRUMENT, SURGICAL, POWERED GEX ALCON - IRVINE TECHNOLOGY CENTER 8065500001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other