BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAMPATH ROBOTIC FIBER

    MDR report key: 12008108 · Received June 15, 2021

    Report

    Report Number
    MW5101899
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 11, 2021
    Manufacturer
    OMNIGUIDE INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LASER FIBER BURNED OUT AFTER 9 SECONDS DURING PROCEDURE. SECOND ONE OBTAINED PROCEDURE CONTINUED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894029 BEAMPATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE INC. LA210301AA-P1

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR