BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS CAPSULE ENDOSCOPE

    MDR report key: 3912361 · Received June 26, 2014

    Report

    Report Number
    8010047-2014-00313
    Event Type
    Other
    Date Received
    June 26, 2014
    Report Date
    May 29, 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 SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVALUATION. OMSC CONCLUDE THAT THIS PHENOMENON WAS POSSIBLY ATTRIBUTED TO THE CONDITION OF THE PATIENT BECAUSE THE FACILITY REPORTED THAT THE PATIENT HAD A STENOSIS THE SMALL INTESTINE. 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 TWO WEEKS AFTER THE PATIENT HAD TAKEN THE EC-1 THE PHYSICIAN COULD NOT BEEN ABLE TO CONFIRM THE ELIMINATION OF THE EC-1 FROM THE PATIENT'S BODY. THE FACILITY REPORTEDLY CONDUCTED AN X-RAY EXAMINATION FOR THE PATIENT AND FOUND THE EC-1 IN THE PATIENT'S ABDOMEN. AN ADDITIONAL BALLOON ENDOSCOPY THROUGH THE ORAL SIDE FOR THE PATIENT WAS CARRIED OUT AND THE EC-1 WAS FOUND AT THE ORAL SIDE OF A SMALL INTESTINE STENOSIS. IT WAS REPORTED THAT THE EC-1 WAS RETRIEVED FROM THE PATIENT DURING THE BALLOON ENDOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373204 OLYMPUS CAPSULE ENDOSCOPE CAPSULE ENDOSCOPE KOG OLYMPUS MEDICAL SYSTEMS CORPORATION EC-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other