BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUVERA 200UM SINGLE USE FLAT TIP FIBER

    MDR report key: 23613649 · Received November 21, 2025

    Report

    Report Number
    3020221089-2025-00001
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 20, 2025
    Manufacturer
    IPG MEDICAL CORPORATION
    Product Code
    GEX
    UDI-DI
    00810071230035
    PMA / PMN Number
    K232568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION REGARDING THE EVENT AND RETURN OF THE DEVICE HAVE BEEN REQUESTED FROM THE REPORTER. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. WITHOUT THE LOT NUMBER OR DEVICE, NO INVESTIGATION CAN BE CONDUCTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FIBER TIP BROKE OFF IN PATIENT. THE PHYSICIAN TRIED TO BASKET OUT THE BROKEN PIECE OF FIBER BUT WAS NOT SUCCESSFUL. NEXT COURSE OF ACTION IS UNKNOWN. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022944 THUVERA 200UM SINGLE USE FLAT TIP FIBER SURGICAL LASER FIBER GEX IPG MEDICAL CORPORATION UNK 00810071230035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown