BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ND YAG LASER

    MDR report key: 4853180 · Received June 18, 2015

    Report

    Report Number
    2028159-2015-06536
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    May 22, 2015
    Report Date
    August 30, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    GEX
    PMA / PMN Number
    K897099
    Removal / Correction Number
    NO
    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 IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE SYSTEM WAS EXAMINED. THE COMPANY REPRESENTATIVE DID NOT INDICATE FINDING ANY ISSUES THAT WOULD BE ASSOCIATED WITH THE REPORTED EVENT. THE ILLUMINATOR PRINTED CIRCUIT BOARD (PCB) CONTROLLER AND A LAMP WERE REPLACED. THE LASER WAS RE-ALIGNED. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. A REVIEW OF THE CUSTOMER¿S COMPLAINT HISTORY FOR THE LAST 24 MONTHS DID NOT SHOW ANY PREVIOUS COMPLAINTS OF THIS KIND AGAINST THE SYSTEM. THE LASER WAS RE-ALIGNED. THE LASER WAS MANUFACTURED ON NOVEMBER 11, 1997. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE LASER WAS NOT TRIGGERING PRIOR TO A PROCEDURE. THE PROCEDURE WAS NOT INITIATED. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396651 ND YAG LASER POWERED LASER SURGICAL INSTRUMENT GEX ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other