BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARYNG-O-JET KIT

    MDR report key: 20202301 · Received September 11, 2024

    Report

    Report Number
    MW5159528
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    August 9, 2024
    Report Date
    September 6, 2024
    Manufacturer
    INTERNATIONAL MEDICATION SYSTEMS/AMPHASTAR PHARMACEUTICALS, INC.
    Product Code
    CCT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PAT WAS IN OPERATING ROOM FOR LAPAROSCOPIC SURGERY FOR INGUINAL HERNIA REPAIR, LEFT SIDE. DURING INTUBATION, THE TIP OF THE LTA KIT BROKE OFF IN THE PATIENT'S AIRWAY. THE PIECE WAS RETRIEVED BY THE ANESTHESIOLOGIST WITH HELP FROM THE GI TEAM USING A BRONCHOSCOPE AND GRASPER. THE PATIENT WAS AWAKENED AND SUCTIONED WITH NO FURTHER INCIDENT. SURGEON CANCELED THE CASE TO MAKE SURE THE PATIENT WAS OK BEFORE RESCHEDULING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505489 LARYNG-O-JET KIT APPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA CCT INTERNATIONAL MEDICATION SYSTEMS/AMPHASTAR PHARMACEUTICALS, INC. 6300 DJ007A4

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention