BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NVISIONVLE OPTICAL PROBE

    MDR report key: 7328626 · Received March 9, 2018

    Report

    Report Number
    3008805841-2018-00001
    Event Type
    Injury
    Date Received
    March 9, 2018
    Date of Event
    February 9, 2018
    Report Date
    February 22, 2018
    Manufacturer
    NINEPOINT MEDICAL, INC.
    Product Code
    NQQ
    PMA / PMN Number
    K153479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE NVISIONVLE OPTICAL PROBE WAS NOT RETURNED, IT COULD NOT BE PHYSICALLY INSPECTED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTER DID INDICATE THAT THE DEVICE DID NOT MALFUNCTION DURING THE PROCEDURE. RELATED WARNINGS IN THE INSTRUCTIONS FOR USE SPECIFY: THIS DEVICE WILL INFLATE TO LABELED DIAMETER AND THEREFORE, SHOULD NOT BE USED IN ANY ANATOMY WHERE THIS SIZE WOULD BE INAPPROPRIATE. STRICTURES, INFLAMMATORY DISEASE OR ESOPHAGEAL MASSES MAY PREVENT THE ADEQUATE EXPANSION OF THE NVISION VLE OPTICAL PROBE.

    Description of Event or Problem · 1

    THE PHYSICIAN SELECTED A 20 MM NVISION OPTICAL PROBE, WHICH CONTAINS A 20 MM BALLOON, FOR THE OCT IMAGING EVALUATION. PATIENT PRESENTED WITH BLEEDING IN SMALL AREA AT THE PROXIMAL END OF THE PATIENT'S 4 CM HERNIA SAC, POST THE IMAGING SCAN. SCAN WAS PERFORMED AND PROBE WAS REMOVED SUCCESSFULLY. AFTER PROBE WAS REMOVED, USING WHITE LIGHT ENDOSCOPY, A SMALL AREA OF BLEEDING WAS NOTICED. THE PHYSICIAN INDICATED THAT THE TIP OF THE OPTICAL MARKING PROBE MAY HAVE CAUSED A SMALL AMOUNT OF TRAUMA WHICH RESULTED IN THE BLEEDING. THE PATIENT PROCEDURE WAS NOT AFFECTED AND CONTINUED AS PLANNED. THE BLEEDING WAS STOPPED WITH HEMO-STATIC CLIPS AND EPINEPHRINE INJECTION AT THE SITE. THE 20 MM NVISION OPTICAL PROBE WAS INADVERTENTLY DISCARDED IN THE SHARPS CONTAINER AND COULD NOT BE EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170051 NVISIONVLE OPTICAL PROBE NVISIONVLE OPTICAL PROBE NQQ NINEPOINT MEDICAL, INC. 95301-M-20 005252

    Patients

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