BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE LASER STD HANDLE CYCLOPHOT

    MDR report key: 21059243 · Received January 2, 2025

    Report

    Report Number
    MW5164176
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 26, 2024
    Report Date
    December 26, 2024
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PROBE LASER STD HANDLE CYCLOPHOTOCOAGULATION MP3 PROBE REF 15522 1EA LOT 801232 EXP - 2027-07-01 REPORTED PRODUCT DID NOT FIRE WHEN ITEM WAS PLUGGED INTO THE IRIDEX MACHINE; OPTHAL. LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431557 PROBE LASER STD HANDLE CYCLOPHOT POWERED LASER SURGICAL INSTRUMENT GEX IRIDEX CORPORATION LOT 801232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other