BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 10114645 · Received June 3, 2020

    Report

    Report Number
    8020889-2020-00031
    Event Type
    Injury
    Date Received
    June 3, 2020
    Date of Event
    April 21, 2020
    Report Date
    June 3, 2020
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE :COMPARISON OF CONVENTIONAL AND FIBREOPTIC-GUIDED ADVANCE OF LEFT-SIDED DOUBLE-LUMEN TUBE DURING ENDOBRONCHIAL INTUBATION SOURCE EUR J ANAESTHESIOL, VOLUME 37, 2020 (466¿473). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, THE ARTICLE EVALUATED THE EFFECTS OF FIBRE OPTIC-GUIDED ADVANCE OF DLT ON POSTOPERATIVE ADVERSE EVENTS SUCH AS SORE THROAT, HOARSENESS, THROAT PAIN, DRYNESS, DYSPHAGIA TRACHEAL INJURY, VOCAL CORD INJURY ASSOCIATED WITH INTUBATION. THERE WERE 123 PATIENTS UNDERWENT ONE-LUNG VENTILATION WITH A LEFT SIDE DOUBLE LUMEN TUBE. THEY WERE DIVIDED IN TWO GROUPS, 62 IN THE CONVENTIONAL GROUP AND 61 IN THE FIBRE OPTIC-GUIDED GROUP. THE SIZE OF THE DEVICE WAS BASED ON THE SEX AND HEIGHT OF THE PATIENT. IT WAS STATED THAT THERE WERE MISPLACEMENT IN 3 PATIENTS AND TRACHEAL AND VOCAL INJURIES IN THE CONVENTIONAL GROUP. NO ADDITIONAL INFORMATION IN TERMS OF WHETHER THERE WAS INTERVENTION AND PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580730 SHILEY TUBE TRACHEOSTOMY AND TUBE CUFF JOH MALLINCKRODT MEDICAL UNKNOWN - SHILEY

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other