BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMINATED FLEX CURVED LASER BROBE, 23GA

    MDR report key: 3964721 · Received June 19, 2014

    Report

    Report Number
    2028159-2014-01148
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQF
    PMA / PMN Number
    K062624
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. 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).

    Description of Event or Problem · 1

    A SURGEON REPORTED EXPERIENCING A FAULTY SPARKING LASER PROBE BEFORE SURGERY. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360924 ILLUMINATED FLEX CURVED LASER BROBE, 23GA LASER, OPHTHALMIC HQF ALCON - IRVINE TECHNOLOGY CTR 8065751592 13029118X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA