BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTONGUIDE

    MDR report key: 11990917 · Received June 14, 2021

    Report

    Report Number
    11990917
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    February 19, 2020
    Report Date
    June 4, 2021
    Manufacturer
    INVUITY, INC.
    Product Code
    FSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE EIKON ILLUMINATED RETRACTOR WAS BEING USED DURING THE PROCEDURE. IT HAD BEEN USED ON THE LEFT BREAST AND REMAINED ON. WHEN THE SURGEON STARTED TO USE IT ON THE RIGHT BREAST, SHE NOTICED THE BULB WAS BURNING, MELTED AND SMOKING, PRIOR TO RETRACTOR BEING PLACED IN THE BREAST POCKET. THE LIGHT SOURCE WAS IMMEDIATELY TURNED OFF, AND THE RETRACTOR WAS REMOVED FROM THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890915 PHOTONGUIDE LIGHT, SURGICAL, CARRIER FSZ INVUITY, INC. WIDE / FLAT 18101602

    Patients

    Seq Age Sex Outcome Treatment
    1 16425 DA