BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAM PATH ROBOTIC FIBER

    MDR report key: 11692952 · Received April 19, 2021

    Report

    Report Number
    MW5100845
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 15, 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

    TWO LASER FIBERS BURNED OUT DURING PROCEDURE. A NEW FIBER WAS OPENED FROM A DIFFERENT LOT THAT WORKED WITHOUT DIFFICULTIES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581061 BEAM PATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC. LA210119AJ-P1
    581062 BEAM PATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR