BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHFINDER ENDOSCOPE OVERTUBE

    MDR report key: 21036387 · Received December 30, 2024

    Report

    Report Number
    3015451828-2024-00009
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    November 22, 2024
    Report Date
    December 18, 2024
    Manufacturer
    NEPTUNE MEDICAL, INC.
    Product Code
    FED
    UDI-DI
    00850006222087
    PMA / PMN Number
    K211301
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO NEPTUNE MEDICAL FOR INVESTIGATION. THE TRIMMING OF THE TIP WAS CONFIRMED BY THE EMPLOYEE THAT PERFORMED THE ACTION. UNKNOWN LOT NUMBER; BASED ON SHIPMENTS TO SITE, DATE OF MANUFACTURE MAY BE IN MAY 2024 OR OCT 2024.

    Description of Event or Problem · 0

    A PATIENT WAS ADMITTED FOR COLONOSCOPY TO REMOVE A FOREIGN BODY THAT HAD MIGRATED TO THE DISTAL COLON. THE MD DETERMINED THAT THE DEVICE WOULD BE A USEFUL TOOL TO HELP WITH THE REMOVAL OF THE FOREIGN BODY, AND REQUESTED THE OVERTUBE FOR THE PROCEDURE. UPON EXAMINATION OF THE DEVICE BY THE PHYSICIAN PERFORMING THE PROCEDURE, THE PHYSICIAN ASKED THAT THE DISTAL TIP (TAPERED PORTION) OF THE DEVICE BE TRIMMED TO CREATE A LARGER WORKING CHANNEL. AT THE REQUEST OF THE MD, A COMPANY EMPLOYEE TRIMMED THE DISTAL TIP USING SCISSORS. THE DEVICE WAS INSERTED INTO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE DEVICE IS A HOLLOW TUBE FOR USE OVER A FLEXIBLE GASTROINTESTINAL ENDOSCOPE. THE ENDOSCOPE IS INSERTED THROUGH THE PROXIMAL END OF THE DEVICE AND COMES OUT THE DISTAL END. THE DISTAL TIP IS A TAPERED, ATRAUMATIC SILICONE TIP THAT IS ATTACHED TO THE DISTAL END OF PATHFINDER. PER INTERNAL DOCUMENTATION, THE POTENTIAL HARM IN THE EVENT THE ATRAUMATIC TIP IS LOST AND THE DEVICE IS INSERTED INTO THE PATIENT IS GI TRACT DAMAGE UP TO AND INCLUDING PERFORATION OF PATIENT ANATOMY REQUIRING SURGICAL INTERVENTION. THERE WAS NO REPORTED ADVERSE EVENT OR HARM OCCURRING IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227213 PATHFINDER ENDOSCOPE OVERTUBE PATHFINDER ENDOSCOPE OVERTUBE FED NEPTUNE MEDICAL, INC. GI 110160-2 UNKNOWN 00850006222087

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other