BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREPOINT LASER

    MDR report key: 6182016 · Received December 16, 2016

    Report

    Report Number
    2028159-2016-05784
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    December 12, 2016
    Report Date
    August 7, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQF
    PMA / PMN Number
    K062624
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWER SUPPLY WAS RECEIVED FOR EVALUATION. A VISUAL ASSESSMENT OF THE RETURNED SAMPLE REVEALED AN ACCUMULATION OF BLACK, POWDERY DEBRIS THROUGHOUT THE PART. THE SAMPLE WAS INSTALLED INTO A KNOWN-GOOD PURE POINT SYSTEM FOR FUNCTIONAL TESTING. ONCE SWITCHED ON, THE TWO FUSES IN THE AC POWER-IN BLEW AND STOPPED THE SYSTEM FROM BOOTING-UP. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A NONCONFORMING POWER SUPPLY. HOWEVER, HOW OR WHEN THIS COMPONENT BECAME NONCONFORMING CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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 IS PROVIDED IN DEVICE AVAILABLE FOR EVALUATION?, DEVICE EVALUATED BY MFR?, EVALUATION CODES. AND ADDITIONAL MFR NARRATIVE. THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT WAS REPLICATED. THE POWER SWITCH AND POWER SUPPLY WERE BOTH REPLACED TO RESOLVE THIS ISSUE. 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 SYSTEM WAS MANUFACTURED ON JULY 13, 2009. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A NONCONFORMING POWER SWITCH AND POWER SUPPLY. HOWEVER, HOW OR WHEN THESE COMPONENTS BECAME NONCONFORMING CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE LASER SHUT DOWN DURING A SURGICAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833604 PUREPOINT LASER LASER, OPHTHALMIC HQF ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other