BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NVISIONVLE LOW-PROFILE OPTICAL PROBE

    MDR report key: 7430612 · Received April 13, 2018

    Report

    Report Number
    3008805841-2018-00003
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Date of Event
    March 15, 2018
    Report Date
    April 13, 2018
    Manufacturer
    NINEPOINT MEDICAL, INC.
    Product Code
    NQQ
    UDI-DI
    00859591006188
    PMA / PMN Number
    K143678
    Removal / Correction Number
    3008805841-04/11/18-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NVISIONVLE® LOW-PROFILE OPTICAL PROBE WAS RETURNED TO NINEPOINT MEDICAL FOR EVALUATION. DEVICE WAS INTACT WITH THE EXCEPTION OF THE SOFT TIP WHICH HAD DETACHED DURING THE PROCEDURE. THE SHEATH IMAGING WINDOW DID NOT APPEAR TO HAVE BEEN STRESSED IN TENSION. HOWEVER, THERE APPEARED TO BE A KINK AT THE END OF THE SHEATH IMAGING WINDOW. THE DEVICE HISTORY RECORD WAS REVIEWED FOR RETURNED NVISIONVLE® LOW-PROFILE OPTICAL PROBE AND NO ANOMALIES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THIS EVENT. RELATED WARNINGS AND PRECAUTIONS IN THE INSTRUCTIONS FOR USE INCLUDE: TO PREVENT FAILURES IN THE NVISIONVLE LOW-PROFILE OPTICAL PROBE, DO NOT KINK OR SHARPLY BEND IT AT ANY TIME. EXTREME ENDOSCOPE MANIPULATIONS MAY RESULT IN BREAKAGE OF THE OPTICAL PROBE. DO NOT USE THE NVISIONVLE LOW-PROFILE OPTICAL PROBE IF THE INNER PACKAGE IS OPEN OR DAMAGED. DO NOT USE THE NVISIONVLE LOW-PROFILE OPTICAL PROBE IF THE DEVICE APPEARS TO BE DAMAGED. THE NVISIONVLE LOW-PROFILE OPTICAL PROBE IS SUPPLIED STERILE AND IS DESIGNED FOR SINGLE-PATIENT USE ONLY. DO NOT REUSE OR RE-STERILIZE THE NVISIONVLE LOW-PROFILE OPTICAL PROBE. THIS DEVICE SHOULD NOT BE USED IN ANY ANATOMY WHERE THE LABELED DIAMETER WOULD BE INAPPROPRIATE.

    Description of Event or Problem · 1

    THE PHYSICIAN SELECTED A NVISIONVLE® LOW-PROFILE OPTICAL PROBE FOR THE OCT IMAGING EVALUATION. IT WAS REPORTED THAT THE SOFT TIP OF THE NVISIONVLE LOW-PROFILE OPTICAL PROBE HAD BECOME DETACHED DURING A PROCEDURE TO IMAGE THE COMMON BILE DUCT. THE TIP DETACHED AFTER REMOVAL OF THE DEVICE FROM THE DUCT POST IMAGING. IT WAS NOTED THAT THERE WAS SIGNIFICANT OVER MANIPULATION REQUIRED TO PLACE THE LOW-PROFILE OPTICAL PROBE INTO THE DESIRED LOCATION DUE TO THE CHALLENGING AND DILATED ANATOMY. THE DETACHED TIP WAS RETRIEVED USING A RAT-TOOTHED FORCEPS. THE PATIENT WAS NOT HARMED IN THIS INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273895 NVISIONVLE LOW-PROFILE OPTICAL PROBE NVISIONVLE LOW-PROFILE OPTICAL PROBE NQQ NINEPOINT MEDICAL, INC. 95501-LP 5275 00859591006188

    Patients

    Seq Age Sex Outcome Treatment
    1