BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BULLARD/LARS-A ELITE

    MDR report key: 740078 · Received July 14, 2006

    Report

    Report Number
    740078
    Event Type
    Injury
    Date Received
    July 14, 2006
    Date of Event
    June 19, 2006
    Report Date
    July 14, 2006
    Manufacturer
    ACMI CORPORATION
    Product Code
    CCW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT A RADICAL PROSTATECTOMY. AT THIS TIME, THE ANESTHESIOLOGIST INTUBATED THE PATIENT USING A BULLARD ADULT INTUBATING LARYNGOSCOPE. THERE IS AN AVAILABLE BLADE EXTENDER, WHICH IS A DISPOSABLE PIECE OF PLASTIC WHICH FITS ON THE BLADE END OF THE LARYNGOSCOPE. IT IS A SINGLE-USE ITEM, INTENDED TO BE REMOVED AND DISCARDED AT THE END OF THE INTUBATION PROCEDURE. APPARENTLY, THE ANESTHESIOLOGIST USED THE BLADE EXTENDER AND DURING THE INTUBATION, THE EXTENDER PIECE BECAME SEPARATED FROM THE LARYNGOSCOPE BLADE AND REMAINED IN THE THROAT OF THE PATIENT. HE HAD DIFFICULTY SWALLOWING FOR SEVERAL DAYS POST-OPERATIVELY AND UNDERWENT AN UPPER ENDOSCOPY. THE PIECE WAS REMOVED IN THE OPERATING ROOM WITH SOME DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BULLARD/LARS-A ELITE BLADE EXTENDER, LARYNGOSCOPE CCW ACMI CORPORATION LARS-A ELITE *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R