BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARYNGOSCOPE, RIGID

    MDR report key: 12287220 · Received August 6, 2021

    Report

    Report Number
    12287220
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 30, 2021
    Report Date
    July 30, 2021
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE EVENT OCCURRED DURING DIRECT LARYNGOSCOPY. STUDENT REGISTERED NURSE ANESTHETIST INSERTED CURAPLEX MILLER 3 BLADE INTO PATIENT'S MOUTH, UNDER SUPERVISION OF CRNA AND ANESTHESIOLOGIST. APPROPRIATELY IDENTIFIED EPIGLOTTIS, ROUTINELY LIFTED SOFT TISSUE TO GAIN VIEW OF GLOTTIC OPENING, WHEN THE MILLER 3 BLADE BROKE INSIDE OF THE PATIENT'S MOUTH. NO HARM OR DAMAGE WAS DONE THE PATIENT'S MOUTH OR TEETH. NO PIECES FELL INTO THE PATIENT'S MOUTH OF ESOPHAGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185374 LARYNGOSCOPE, RIGID CCW BOUND TREE MEDICAL, LLC 301-FO-MIL-3-S

    Patients

    Seq Age Sex Outcome Treatment
    1 27010 DA