BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G STRAIGHT ENDOPROBE® SINGLE

    MDR report key: 16806194 · Received April 25, 2023

    Report

    Report Number
    16806194
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    January 27, 2023
    Report Date
    April 12, 2023
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    20G STRAIGHT ENDOPROBE SINGLE WAS NOT OPERATING PROPERLY. THE LASER WAS NOT FIRING AND WAS PRODUCING A WHITE SMOKE. LAWSON NUMBER 200418, REFERENCE NUMBER 10562-1, EXPIRATION 04/01/2025. THE LOT NUMBER WAS REMOVED FROM PYXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429923 20G STRAIGHT ENDOPROBE® SINGLE POWERED LASER SURGICAL INSTRUMENT GEX IRIDEX CORPORATION 10562-1 900748

    Patients

    Seq Age Sex Outcome Treatment
    1 22265 DA Male