BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NVISIONVLE MARKING PROBE

    MDR report key: 6329110 · Received February 14, 2017

    Report

    Report Number
    3008805841-2017-00001
    Event Type
    Injury
    Date Received
    February 14, 2017
    Date of Event
    January 17, 2017
    Report Date
    February 14, 2017
    Manufacturer
    NINEPOINT MEDICAL, INC.
    Product Code
    NQQ
    UDI-DI
    00859591006072
    PMA / PMN Number
    K153479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    AN NVISIONVLE MARKING PROBE (20MM) WAS PLACED THROUGH THE ENDOSCOPE INTO THE STOMACH. DURING THE PROCEDURE THE BALLOON WAS NOT INFLATING AS QUICKLY AS EXPECTED, THEREFORE A DECISION WAS MADE TO USE A NEW MARKING PROBE. THE PROCEDURE WAS ABORTED, AND THE REMAINING AIR WAS SUCTIONED TO DEFLATE THE BALLOON, HOWEVER THE PHYSICIAN PREMATURELY PULLED THE MARKING PROBE BACK THROUGH THE ENDOSCOPE AND THE BALLOON DETACHED FROM THE MARKING PROBE AND LODGED IN THE ENDOSCOPE CHANNEL. THE PHYSICIAN DECIDED TO ADVANCE THE SCOPE INTO THE STOMACH AND PUSH THE BALLOON FROM THE ENDOSCOPE CHANNEL USING BIOPSY FORCEPS INTO THE STOMACH. A SNARE WAS USED TO OBTAIN THE BALLOON FROM THE STOMACH. THE PATIENT WAS UN-HARMED, AND CASE COMPLETED USING THE NEW MARKING PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111606 NVISIONVLE MARKING PROBE NVISIONVLE MARKING PROBE NQQ NINEPOINT MEDICAL, INC. 95301-M-20 004904 00859591006072

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ENDOSCOPE (NO MFGR SPECIFIED)