BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25 GA CURVED LASER PROBE

    MDR report key: 23497412 · Received November 7, 2025

    Report

    Report Number
    2529392-2025-00002
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    June 27, 2024
    Report Date
    November 7, 2025
    Manufacturer
    PEREGRINE SURGICAL LLC
    Product Code
    HQB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE IS UNABLE TO BE DETERMINED SINCE THE PHYSICAL PRODUCT WAS NOT RETURNED AND LOT NUMBER IS UNKNOWN. WITHOUT THE LOT NUMBER NEITHER DHR OR TRAINING DOCUMENTATION REVIEW CAN BE CONDUCTED. WE WILL MONITOR THE TREND OF THE COMPLAINT AND TAKE APPROPRIATE MEASURE TO ELIMINATE THE NATURE OF THE OCCURENCE.

    Description of Event or Problem · 0

    STELLARIS AND LASER DID NOT WORK TOGETHER; THERE WAS POWER LACKING AND SURGEON NEEDED TO PUT THE POWER TO MAX TO GET A DECENT LASER BEAM. AFTER THAT THE POWER CAME BACK AND THE RETINA GOT DAMAGED. THERE MUST BE SOMETHING WRONG WITH LASER/CONNECTION/POWER OUTPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172143 25 GA CURVED LASER PROBE DISPOSABLE PACKS HQB PEREGRINE SURGICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention