BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EIGR¿ WAVEGUIDE

    MDR report key: 6263139 · Received January 19, 2017

    Report

    Report Number
    6263139
    Event Type
    Malfunction
    Date Received
    January 19, 2017
    Date of Event
    December 14, 2016
    Report Date
    January 18, 2017
    Manufacturer
    INVUITY, INC.
    Product Code
    FST
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THYROIDECTOMY SURGEON NOTED THAT WHILE USING LIGHTED RETRACTOR DURING THE PROCEDURE, THE RETRACTOR WAS GETTING HOT TO THE TOUCH. STAFF TURNED DOWN THE INTENSITY OF LIGHT SOURCE. AFTER THE PROCEDURE WAS FINISHED A REDDENED STREAK WAS NOTED ON THE PATIENT'S SKIN. STAFF SEQUESTERED THE LIGHT SOURCE AND EQUIPMENT AND THE RETRACTOR WAS NOTED TO HAVE A CRACK IN IT. THE PATIENT DID NOT NEED FURTHER TREATMENT AND DID NOT SUSTAIN SIGNIFICANT HARM. DEVICE WAS NOT CRACKED AT BEGINNING OF CASE. MANUFACTURER RESPONSE FOR LIGHTED RETRACTOR, EIGR WAVEGUIDE, NARROW/FLAT (PER SITE REPORTER): THEY WISH TO ANALYZE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45963 EIGR¿ WAVEGUIDE LIGHT, SURGICAL, FIBEROPTIC FST INVUITY, INC. NARROW / FLAT, LC 16032301

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other NO OTHER THERAPIES