BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA II BRONCHOVIDEAOSCOPE

    MDR report key: 2983281 · Received February 4, 2013

    Report

    Report Number
    8010047-2013-00036
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    October 6, 2012
    Report Date
    January 7, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE FOREIGN OBJECT WAS DETECTED DURING A THERAPEUTIC BRONCHOSCOPY PROCEDURE. THE PT REPORTEDLY HAD A PREVIOUS BRONCHOSCOPY 5 DAYS PRIOR TO THIS REPORTED EVENT. THE FOREIGN OBJECT WAS SAID TO HAVE BEEN RETRIEVED WITH A DORMIA BASKET. THE FOREIGN OBJECT WAS SAID TO BE SMALL WITH NO SHARP EDGE. THERE WAS NO COMPLICATION NOTED DURING THE PROCEDURE AND THE PT WAS SAID TO HAVE BEEN TRANSFERRED TO TRANSITIONAL CARE PRIOR TO HOME. THE USER FACILITY FURTHER REPORTED THAT THE REFERENCED DEVICE WAS LAST FORWARDED TO A THIRD PARTY VENDOR ON (B)(4) 2012. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL REVEALED THAT THE DEVICE FAILED THE LEAK TEST DUE TO A HOLD ON THE BENDING SECTION COVER GLUE AND TORN BENDING SECTION. THE INSERTION TUBE WAS BUCKLED AND SCRATCHED. THE DEVICE WAS REFURBISHED.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MAUDE EVENT REPORT, WHICH STATED: "BRONCHOSCOPY DONE. FOREIGN BODY NOTED IN LEFT LOWER LOBE. UPON RETRIEVAL, APPEARED TO BE RISK FROM DISTAL TIP OF BRONCHOSCOPE. BRONCHOSCOPE EXAMINED AND CONFIRMED TIP FROM SCOPE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47389 OLYMPUS EVIS EXERA II BRONCHOVIDEAOSCOPE BRONCHOSCSOPE EOQ OLYMPUS MEDICAL SYSTEMS CORPORATION BF-Q180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR TRACHEOTOMY TUBE| DORMIA BASKET