BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA II BRONCHOVIDEOSCOPE

    MDR report key: 2010337 · Received February 11, 2011

    Report

    Report Number
    8010047-2011-00025
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    December 9, 2010
    Report Date
    January 14, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS CONTACTED THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE DISTAL END COVER OF THE TIP WAS STILL ATTACHED AND NO DEVICE FRAGMENT HAD FALLEN INTO THE PT'S BODY CAVITY. THE SUBJECT DEVICE WAS REPORTEDLY EVALUATED PRIOR TO PROCEDURE AND WAS FOUND FUNCTIONING PROPERLY; HOWEVER, THE TUBE IN WHICH THE BRONCHOSCOPE HAD BEEN INSERTED WAS SAID TO BE SMALL. AN X-RAY WAS SAID TO HAVE BEEN PERFORMED ON THE PT AT THE END OF THE PROCEDURE WITH NO ANOMALIES NOTED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE DEVICE WAS RECEIVED WITH THE DISTAL END COVER, OBJECTIVE LENS, AND LIGHT GUIDE LENSES MISSING. THE BENDING SECTION COVER WAS TORN, AND THE DISTAL END BENDING SECTION GLUE WAS ALSO MISSING. THE EVAL FOUND THE DISTAL END UNIT MISSING FROM THE BENDING SECTION AREA. ADDITIONALLY, THE BENDING SECTION UNIT WAS DENTED. THE REPORTED PHENOMENON WAS DETERMINED TO BE DUE TO PHYSICAL DAMAGE. THE DEVICE HAS BEEN REFURBISHED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC BRONCHOSCOPY PROCEDURE, WHILE WITHDRAWING THE ENDOSCOPE FROM THE PT, THE DISTAL TIP OF THE ENDOSCOPE WAS RIPPED OFF. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER BRONCHOSCOPE. THERE WAS NO PT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 GASTROSCOPE| UNSPECIFIED MODEL AND SERIAL NUMBER OF A| UNSPECIFIED MODEL AND SERIAL NUMBER OF AN| ENDOSCOPE