BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS CAPSULE ENDOSCOPE

    MDR report key: 3270810 · Received August 2, 2013

    Report

    Report Number
    8010047-2013-00232
    Event Type
    Injury
    Date Received
    August 2, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KOG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCED DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVALUATION. OMSC EVALUATED THE REFERENCED DEVICE AND FOUND THAT IT HAD NO ABNORMALITY. THE EXACT CAUSE OF THE PATIENT'S OUTCOME CAN NOT BE CONCLUSIVELY DETERMINED, HOWEVER IT IS GENERALLY KNOWN AS THAT ELDERLY PERSON HAS A TENDENCY OF AN ASPIRATION. THEREFORE THERE IS THE POSSIBILITY OF THIS PHENOMENON IS ATTRIBUTED TO THE CONDITION OF THE PATIENT. ALSO, OMSC CHECKED THE MANUFACTURE HISTORY OF THE SUBJECT DEVICE, THERE WAS NO IRREGULARITY FOUND. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. 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 THE ASPIRATION INTO THE TRACHEA HAD OCCURRED WHEN THE PATIENT HAD TAKEN THE EC-1 TO EXAMINE FOR THE PRESENCE OF THE SMALL-BOWEL BLEEDING. SINCE THE PATIENT HAD BEEN NOT ABLE TO BRING UP THE EC-1 BY HIMSELF, THE PHYSICIAN HAD REMOVED THE EC-1 BY USING UNSPECIFIED BRONCHOSCOPE AND UNSPECIFIED ENDOTHERAPY TOOL. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT HAD BEEN ELDERLY ((B)(6)) AND SIMI-BEDRIDDEN. ALSO HE HAD TAKEN THE EC-1 WITH A SMALL SIP OF WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362289 OLYMPUS CAPSULE ENDOSCOPE CAPSULE ENDOSCOPE KOG OLYMPUS MEDICAL SYSTEMS CORPORATION EC-1 34H

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other