BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTERO

    MDR report key: 3173367 · Received June 6, 2013

    Report

    Report Number
    3173367
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 4, 2013
    Report Date
    June 6, 2013
    Manufacturer
    CARL ZEISS MEDITEC, INC.
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    ENT SURGEON NOTED POOR DESIGN IN THE HAND CONTROLS OF THE PENTERO 900 MICROSCOPE. HAND CONTROL FOR THE LIGHT INTENSITY CAN BE INADVERTENTLY MANIPULATED AND CAUSE AN UNSAFE INCREASE IN LIGHT INTENSITY THAT CAN POTENTIALLY CAUSE HARM AND BURN PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UNKNOWNDEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252030 PENTERO MICROSCOPE, SURGICAL EPT CARL ZEISS MEDITEC, INC. 900 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *