BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI VERSALIGHT W/EXTENDED FRAZIER TIP

    MDR report key: 21889979 · Received April 23, 2025

    Report

    Report Number
    21889979
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 21, 2025
    Manufacturer
    BOSS INSTRUMENTS, LTD
    Product Code
    FDG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE IRRIGATION PORT FAILED TO WORK. A NEW MINI VERSALIGHT WAS OPENED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272480 MINI VERSALIGHT W/EXTENDED FRAZIER TIP RETRACTOR, FIBEROPTIC FDG BOSS INSTRUMENTS, LTD 2045:001

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male