BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHANNELSCOPE NEUROENDOSCOPE 30K

    MDR report key: 2885018 · Received December 18, 2012

    Report

    Report Number
    2021898-2012-00433
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K002572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE, AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE EXPANSION RING STATE THAT IT IS INDICATED FOR USE WITH ALL MEDTRONIC NEUROSURGERY ENDOSCOPES WITH THE EXCEPTION OF THE MEDTRONIC NEUROSURGERY 30K HIGH RESOLUTION NEUROENDOSCOPE. ADDITIONAL PT INFO: THE PT IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING A SURGERY THE NEUROENDOSCOPE LOST VISUALIZATION AND AN ARTERY WAS INADVERTENTLY HIT. THE PT HAD A LOT OF BLOOD LOSS AND REQUIRED TWO LITERS OF BLOOD TRANSFUSION. IT WAS ALSO REPORTED THAT THE EXPANSION RING FOR 10K NEUROENDOSCOPES WAS USED WITH THE 30K NEUROENDOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHANNELSCOPE NEUROENDOSCOPE 30K JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| L| R