BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS CAPSULE ENDOSCOPE

    MDR report key: 3760923 · Received April 9, 2014

    Report

    Report Number
    8010047-2014-00158
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 14, 2014
    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 REFERENCE DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OSMC) FOR EVALUATION. OMSC EVALUATED THE REFERENCED DEVICE AND FOUND THAT IT HAD NO ABNORMALITY. THE EXACT CAUSE OF THE PATIENT'S OUTCOME CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, THERE IS THE POSSIBILITY OF THIS PHENOMENON IS ATTRIBUTED TO THE UNDERLYING DISEASE (CROHN DISEASE) 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 PATIENT WHO HAD BEEN SUSPECTED CROHN DISEASE WITH THE STENOSIS OF THE INTESTINE HAD TAKEN THE EC-1 TO EXAMINE THE GASTROINTESTINAL TRACT. NINE DAYS LATER THE EC-1 HAD NOT BEEN EXCRETED FROM THE PATIENT. AFTER THREE DAYS MORE THE PHYSICIAN HAD TAKEN ENDOSCOPY TO RETRIEVE THE EC-1 AND IT HAD BEEN SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213236 OLYMPUS CAPSULE ENDOSCOPE CAPSULE ENDOSCOPE KOG OLYMPUS MEDICAL SYSTEMS CORPORATION EC-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other