BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRIDEX MICROPULSE P3 PROBE

    MDR report key: 15121442 · Received July 27, 2022

    Report

    Report Number
    MW5111153
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    July 18, 2022
    Report Date
    July 25, 2022
    Manufacturer
    IRIDEX CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERGOING A DIODE CYCLO PHOTOCOAGULATION PROCEDURE USING THE MICROPULSE P3 DEVICE INCURRED AN UNINTENTIONAL BURN WHILE THE PHYSICIAN WAS PERFORMING THE PROCEDURE. THE PHYSICIAN STOPPED THE PROCEDURE AND INTERNAL PROBE CHARRING WAS SEEN IN THE HANDPIECE. THE COMPANY WAS NOTIFIED OF THE EVENT. THE COMPANY SAID THEY HAVE HAD A FEW BURNS REPORTED IN THE LAST 6-8 MONTHS AND AN INVESTIGATION IS IN PROGRESS. THE PHYSICIAN AND SURGERY CENTER WERE NOT AWARE OF THE ISSUES WITH THE DEVICE. THE COMPANY HAS INSTRUCTED THE PHYSICIAN AND SURGERY CENTER TO CONTINUING USING THE DEVICES IF COMFORTABLE. MANUFACTURER: IRIDEX PRODUCT: MICROPULSE P3 DEVICE SINGLE, LOT # 870033, REF # (B)(4). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427036 IRIDEX MICROPULSE P3 PROBE POWERED LASER SURGICAL INSTRUMENT GEX IRIDEX CORP. 870033

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other