BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIGUIDE LABER FIBER

    MDR report key: 10453891 · Received August 25, 2020

    Report

    Report Number
    MW5096274
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    August 20, 2020
    Report Date
    August 24, 2020
    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

    ROBOTIC FIBER WAS FOUND WITH A SMALL BENT. NEW ONE OBTAINED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911127 OMNIGUIDE LABER FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC. LA 191204AB-P1

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR