BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTONGUIDE, WIDE/FLAT

    MDR report key: 11010486 · Received December 11, 2020

    Report

    Report Number
    MW5098341
    Event Type
    Malfunction
    Date Received
    December 11, 2020
    Date of Event
    October 22, 2020
    Report Date
    December 9, 2020
    Manufacturer
    INVUITY, INC.
    Product Code
    FSX
    UDI-DI
    00816728020646
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BULB MELTED DURING PROCEDURE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459381 PHOTONGUIDE, WIDE/FLAT LIGHT, SURGICAL, CARRIER FSX INVUITY, INC. Wide / Flat AB20013104 00816728020646

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR