BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NVISIONVLE LOW-PROFILE OPTICAL PROBE

    MDR report key: 7430716 · Received April 13, 2018

    Report

    Report Number
    3008805841-2018-00004
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Date of Event
    January 31, 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

    AS A RESULT OF BECOMING AWARE OF ADDITIONAL INFORMATION THAT WAS LEARNED THROUGH MDR REPORT#3008805841-2018-00003 A REVIEW OF SIMILAR COMPLAINTS WAS UNDERTAKEN. ONE WAS IDENTIFIED REQUIRING REASSESSMENT OF THE PRIOR MDR DETERMINATION, RESULTING IN THIS REPORT. 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. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE RETURNED NVISIONVLE® LOW-PROFILE OPTICAL PROBE AND NO ANOMALIES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THIS EVENT. INVESTIGATION IS ON-GOING. RELATED WARNINGS AND PRECAUTIONS IN THE INSTRUCTIONS FOR USE INCLUDE: 1. TO PREVENT FAILURES IN THE NVISIONVLE LOW-PROFILE OPTICAL PROBE, DO NOT KINK OR SHARPLY BEND IT AT ANY TIME. 2. EXTREME ENDOSCOPE MANIPULATIONS MAY RESULT IN BREAKAGE OF THE OPTICAL PROBE. 3. DO NOT USE THE NVISIONVLE LOW-PROFILE OPTICAL PROBE IF THE INNER PACKAGE IS OPEN OR DAMAGED. 4. DO NOT USE THE NVISIONVLE LOW-PROFILE OPTICAL PROBE IF THE DEVICE APPEARS TO BE DAMAGED. 5. THE NVISIONVLE LOW-PROFILE OPTICAL PROBE IS SUPPLIED STERILE AND IS DESIGNED FOR SINGLE-PATIENT USE ONLY. 6. DO NOT REUSE OR RE-STERILIZE THE NVISIONVLE LOW-PROFILE OPTICAL PROBE. 7. 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. THE OPTICAL PROBE WAS PLACED INSIDE THE COMMON BILE DUCT AND IMAGING WAS PERFORMED SUCCESSFULLY. IT WAS REPORTED THAT THE SOFT TIP OF THE OPTICAL PROBE HAD BECOME DETACHED INSIDE THE ENDOSCOPE DURING REMOVAL. THE PHYSICIAN REMOVED THE SCOPE FROM THE PATIENT AND REMOVED THE OPTICAL PROBE SOFT TIP FROM THE SCOPE. NO MEDICAL INTERVENTION WAS NECESSARY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272702 NVISIONVLE LOW-PROFILE OPTICAL PROBE NVISIONVLE LOW-PROFILE OPTICAL PROBE NQQ NINEPOINT MEDICAL, INC. 95501-LP 5251 00859591006188

    Patients

    Seq Age Sex Outcome Treatment
    1