BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVUITY

    MDR report key: 6528558 · Received April 27, 2017

    Report

    Report Number
    3011394215-2017-00002
    Event Type
    Injury
    Date Received
    April 27, 2017
    Date of Event
    March 20, 2017
    Report Date
    March 28, 2017
    Manufacturer
    INVUITY, INC
    Product Code
    GAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETRACTOR LOT NUMBER WAS NOT PROVIDED THUS A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE WAVEGUIDE LOT HISTORY RECORD WAS REVIEWED, AND NO ISSUES WERE IDENTIFIED. THE WAVEGUIDE USED IN THE CASE WAS DISCARDED, THUS A PHYSICAL EVALUATION COULD NOT BE PERFORMED. THE TESTING PERFORMED IN-HOUSE USING SIMILAR PRODUCTS DEMONSTRATED THAT THE RETRACTOR, WAVEGUIDE, AND CABLE DID NOT EXHIBIT ANY HIGH TEMPERATURE.

    Description of Event or Problem · 1

    A MINOR BURN WAS OBSERVED AT THE END OF A LUMPECTOMY CASE, AT THE INCISION NEAR THE PERIAREOLAR AREA. THE PHYSICIAN REMOVED THE BURNED AREA AND COMPLETED THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307352 INVUITY EIKON LT RETRACTOR, 40MM, EXTRA NARROW GAD INVUITY, INC C40XN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ISOLUX FIBER OPTIC ILLUMINATOR, MULTI POT| PHOTONGUIDE, NARROW/FLAT| SINGLE FIBER OPTIC CABLE, 10FT