BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STORZ ICG LIGHT SOURCE

    MDR report key: 7826519 · Received August 28, 2018

    Report

    Report Number
    MW5079463
    Event Type
    Injury
    Date Received
    August 28, 2018
    Date of Event
    June 25, 2018
    Report Date
    August 26, 2018
    Manufacturer
    KARL STORZ IMAGING, INC.
    Product Code
    OAY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT SUSTAINED 5MM SKIN BURN FROM LIGHT CORD THAT WAS CONNECTED TO STORZ ICG LIGHT SOURCE WHICH AUTOMATICALLY DEFAULTS TO 100%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666437 STORZ ICG LIGHT SOURCE LIGHT SOURCE SYSTEM, DIAGNOSTIC ENDOSCOPIC OAY KARL STORZ IMAGING, INC. 201337 20

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention