BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKOWN CYTOLOGY BRUSH

    MDR report key: 16589479 · Received March 22, 2023

    Report

    Report Number
    1220592-2023-00002
    Event Type
    Injury
    Date Received
    March 22, 2023
    Report Date
    March 20, 2023
    Manufacturer
    HOBBS MEDICAL, INC.
    Product Code
    FDX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WAITING CONFIRMATION FROM STUDY AUTHOR TO CONFIRM IF HOBBS MEDICAL DEVICES WERE INVOLVED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, PROSPECTIVE STUDY EVALUATED THE ROLE OF OPERATORS' EXPERIENCE AS WELL AS LESION- AND PROCEDURE CHARACTERISTICS ON DIAGNOSTIC YIELD OF ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) PROCEDURES IN THE HANDS OF NOVICE ENB OPERATORS. PATIENTS UNDERWENT ENB PROCEDURES BETWEEN MAY 2018 AND FEBRUARY 2020. ALL PROCEDURES WERE PERFORMED USING THE SUPERDIMENSION NAVIGATION SYSTEM 7.1. 215 PROCEDURES WERE PERFORMED WITH FORCEPS USED IN 190 PATIENTS, NEEDLE USED IN 42 PATIENTS AND CYTOBRUSHES USED IN 120 PATIENTS. COMPLICATIONS INCLUDED: BRONCHIAL HEMORRHAGE REQUIRING A BALLOON CATHETER IN 1 PATIENT AND PNEUMOTHORAX REQUIRING CHEST TUBE INSERTION IN 2 PATIENTS. PUBLICATION TITLE: DIAGNOSTICS. ARTICLE TITLE: WHEN PULMONOLOGISTS ARE NOVICE TO NAVIGATIONAL BRONCHOSCOPY, WHAT PREDICTS DIAGNOSTIC YIELD? DATE: 12 DECEMBER 2022. HOBBS MEDICAL BRUSHES ARE DISTRIBUTED AS SUPERDIMENSION-BRANDED ACCESSORIES TO THE SUPERDIMENSION NAVIGATION SYSTEM. NO MALFUNCTION OF ANY DEVICE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905120 UNKOWN CYTOLOGY BRUSH CYTOLOGY BRUSH FDX HOBBS MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R