BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDOVATIONS INNERVISION TRANSILLUMINATION SYSTEM

    MDR report key: 1520461 · Received October 29, 2009

    Report

    Report Number
    MW5013284
    Event Type
    Injury
    Date Received
    October 29, 2009
    Date of Event
    September 8, 2009
    Report Date
    October 29, 2009
    Manufacturer
    MEDOVATIONS, INC.
    Product Code
    KNQ
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CRNA PLACED BOUGIE TIP, CRNA STATED TIP WAS DIFFICULT TO ADVANCE, THEREFORE, CRNA REMOVED TIP AND APPLIED LUBRICATION AND RE-INSERTED THE TIP WITHOUT FURTHER DIFFICULTY. DURING PROCEDURE, THE CRNA NOTED THE BOUGIE TIP WAS DISCONNECTED FROM THE LIGHT CABLE. SURGEON WAS IMMEDIATELY NOTIFIED. STAT EGD WAS PERFORMED AND THE BOUGIE TIP WAS LOCATED AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDOVATIONS INNERVISION TRANSILLUMINATION SYSTEM DETACHABLE BOUGIE TIP KNQ MEDOVATIONS, INC. 56 FRENCH 209091

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Disability