BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G-PROBE RFID

    MDR report key: 16684037 · Received April 4, 2023

    Report

    Report Number
    MW5116356
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 29, 2023
    Report Date
    April 3, 2023
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MD REPORTED PRODUCT G-PROBE RFID FROM IRIDEX REF (B)(4) MALFUNCTIONED LEFT MARK ON PATIENT. ADVERSE EVENT NO HARM. LOT #S 900898 AND 900910. QUARANTINED FROM ENTIRE SURGERY INVENTORY. MACHINE MODEL: CYCLO G6 SN:(B)(4). QUARANTINED BY BIOMED AND SERVICE REQUEST INITIATED. LOANER MACHINE REQUESTED. NEW INVENTORY OVERNIGHT SHIPPED 3/30/23. ITEM LOT #S CONFIRMED WITH COMPANY AND NO ACTIVE RECALLS. NEW LOT # 200138 READY FOR USE IN EMERGENCY ADD-ON CASE (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416101 G-PROBE RFID POWERED LASER SURGICAL INSTRUMENT GEX IRIDEX CORPORATION 15980 900898 AND 900910

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male