BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BULLARD LARYNGOSCOPE

    MDR report key: 495339 · Received November 5, 2003

    Report

    Report Number
    MW1030079
    Event Type
    Injury
    Date Received
    November 5, 2003
    Date of Event
    November 1, 2003
    Report Date
    November 5, 2003
    Manufacturer
    CIRCON ACMI
    Product Code
    EQN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED FOR ELECTIVE BACK SURGERY, TO BE DONE IN THE PRONE POSITION. IT WAS NOT POSSIBLE TO INTUBATE USING CONVENTIONAL LARYNGOSCOPES, AND REQUIRED A BULLARD LARYNGOSCOPE WITH A PLASTIC EXTENSION TIP. MIDWAY THROUGH THE SURGERY, REPORTER DISCOVERED THEY COULD NOT ACCOUNT FOR THE TIP. PRIOR TO EXTUBATION A LARYNGOSCOPE WAS USED TO SEARCH FOR THE TIP. IT WAS NOT FOUND. THREE DAYS POST-OP PT CONTINUED TO COMPLAIN OF SORE THROAT AND DEVELOPED MILD STRIDOR. FLEXIBLE ENDOSCOPY SHOWED TIP IN HYPOPHARYNX. PT REQUIRED URGENT FIBEROPTIC INTUBATION FOR FB RETRIEVAL AND EXAM UNDER ANESTHESIA. NO PERMANENT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BULLARD LARYNGOSCOPE LARYNGOSCOPE EQN CIRCON ACMI * *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention