BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYN OMNI VELOCITY HIGH PERFORMANCE FIBER LASER PROBE

    MDR report key: 10800791 · Received November 5, 2020

    Report

    Report Number
    MW5097681
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    November 2, 2020
    Report Date
    November 3, 2020
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROBE APPEARED TO OVERHEAT AND MALFUNCTION X 2 PROBES. GYN OMNI LASER PROBE X 2 APPEARED TO MALFUNCTION MD STATED PROBE OVERHEATED WHILE IN USE, CHANGED PROBE ALSO MALFUNCTIONED REP SAID DEFECTIVE PROBE VELOCITY HIGH PERFORMANCE FIBERRFE.332005, LOT LA181026AT-P1, EXP 11-30-2020, AND VELOCITY HIGH PERFORMANCE FIBER REF: 33205, LOT # 181218CN-P1. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255007 GYN OMNI VELOCITY HIGH PERFORMANCE FIBER LASER PROBE POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC. LA181026AT-P01
    1255008 GYN OMNI VELOCITY HIGH PERFORMANCE FIBER LASER PROBE POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC. LA181208CN-P1

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR