BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NVISIONVLE OPTICAL PROBE

    MDR report key: 5772349 · Received July 6, 2016

    Report

    Report Number
    3008805841-2016-00002
    Event Type
    Injury
    Date Received
    July 6, 2016
    Date of Event
    June 8, 2016
    Report Date
    July 6, 2016
    Manufacturer
    NINEPOINT MEDICAL, INC.
    Product Code
    NQQ
    PMA / PMN Number
    K143678
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NVISIONVLE OPTICAL PROBE WAS RETURNED FOR EVALUATION IN MULTIPLE PIECES, WITH THE BALLOON DETACHED. PER THE INITIAL REPORTERS' STATEMENT FROM THE PROCEDURE, THE NURSE PREMATURELY TRIED TO PULL THE OPTICAL PROBE THROUGH THE ENDOSCOPE PRIOR TO DEFLATION COMPLETING, DETACHING THE BALLOON. WITHIN THE PRECAUTIONS OF THE NVISIONVLE OPTICAL PROBE INSTRUCTIONS FOR USE IT STATES "WHEN DRAWING THE OPTICAL PROBE INTO THE ENDOSCOPE, IF PILLOWING IS OBSERVED, STOP AND EITHER REINFLATE AND DEFLATE, OR REMOVE THE OPTICAL PROBE AND SCOPE AS A SYSTEM."

    Description of Event or Problem · 1

    AN NVISIONVLE OPTICAL PROBE (20MM) WAS PLACED THROUGH THE ENDOSCOPE INTO THE STOMACH. DURING THE PROCEDURE THE BALLOON WAS NOT HOLDING PRESSURE AS DESIGNED. THE PROCEDURE WAS ABORTED, AND THE REMAINING AIR WAS SUCTIONED TO DEFLATE THE BALLOON, HOWEVER THE NURSE PREMATURELY PULLED THE OPTICAL PROBE BACK THROUGH THE ENDOSCOPE AND THE BALLOON BECAME LODGED AT THE OPENING OF THE ENDOSCOPE CHANNEL. EXCESSIVE FORCE USED BY THE NURSE RIPPED THE BALLOON OFF THE CATHETER LEAVING IT IN THE ESOPHAGUS. BIOPSY FORCEPS WERE USED TO RETRIEVE THE BALLOON FROM THE ESOPHAGUS. PATIENT WAS UN-HARMED, THE AIRWAY WAS NOT OCCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427936 NVISIONVLE OPTICAL PROBE NVISIONVLE OPTICAL PROBE NQQ NINEPOINT MEDICAL, INC. 95101-20 004777

    Patients

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