BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS EVIS EXERA II BRONCHOVIDEOSCOPE

    MDR report key: 3201771 · Received June 28, 2013

    Report

    Report Number
    8010047-2013-00215
    Event Type
    Injury
    Date Received
    June 28, 2013
    Report Date
    June 5, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    EOQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL CONFIRMED THE USER'S REPORT. THE EVAL FOUND A PORTION OF THE BENDING SECTION RUBBER TORN OFF, AND THE REMAINDER BENDING SECTION RUBBER MEASURED AT 25MM IN LENGTH. THERE WERE MULTIPLE BITE MARKS OBSERVED ON THE SURFACE OF THE INSERTION TUBE AND IT WAS DEFORMED. THE DEVICE WAS SUBSEQUENTLY EVALUATED WITH A VIDEO PROCESSOR WITH HORIZONTAL LINES NOTED ON THE IMAGE. THE IMAGE WOULD ALSO BLACKOUT AND THESE IMAGE PROBLEMS WERE ATTRIBUTED TO A DAMAGED CCD UNIT.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE RUBBER WAS MISSING. THERE WAS NO FURTHER DETAIL PROVIDED. OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE EVENT OCCURRED DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE WHERE THE BRONCHOSCOPE WAS USED IN CONJUNCTION WITH AN 7FR SINGLE USE CUFFED ENDOTRACHEAL TUBE. THE BRONCHOSCOPE REPORTEDLY BECAME STUCK DURING THE PROCEDURE AND THE USERS HAD TO CUT THE TIP OF THE ENDOTRACHEAL TUBE AS A RESULT. THE PT REPORTEDLY SUFFERED RESPIRATORY DISTRESS. THE INTENDED PROCEDURE WAS COMPLETED WITH A DIFFERENT BRONCHOSCOPE. THE USERS REPORTED THAT NO DEVICE FRAGMENT HAD DISLODGED IN THE PT'S AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294971 OLYMPUS EVIS EXERA II BRONCHOVIDEOSCOPE BRONCHOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORPORATION BF-1T180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other UNKNOWN MANUFACTURER| 7FR SINGLE USE ENDOTRACHEAL TUBE WITH