BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS ENDOCAPSULE

    MDR report key: 2507511 · Received March 20, 2012

    Report

    Report Number
    8010047-2012-00078
    Event Type
    Other
    Date Received
    March 20, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 21, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THE REPORT, AND WAS INFORMED THAT ON (B)(6) 2012 THE PHYSICIAN ATTEMPTED TO RETRIEVE THE CAPSULE FROM THE PT WITH THE USE OF AN ENDOSCOPE, WITHOUT SUCCESS. THE INTESTINAL TRACT OF THE PT WAS SAID TO BE ROUGH, THE PT HAD ULCERS AND THERE A PART THAT A MUSCULATURE WAS EXPOSED. THE PHYSICIAN PERFORMED BIOPSY AS NEEDED. THE PHYSICIAN REPORTED THAT THERE WERE STRICTURES THAT WAS NOT ABLE TO VIEW BEFORE PERFORMING THE CAPSULE ENDOSCOPY, AS A RESULT HE WAS NOT ABLE TO INSERT AN ENDOSCOPE TO THE TARGET AREA. THE PHYSICIAN IS GOING TO REMOVE A CAPSULE ENDOSCOPE ON A SURGICAL PROCEDURE. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER THE PT'S ANATOMY AND/OR DISEASE CANNOT BE RULED OUT AS CONTRIBUTORY FACTORS. IF SIGNIFICANT ADDITIONAL INFO 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 CAPSULE ENDOSCOPE WAS RETAINED INSIDE THE PT AFTER THE INITIAL EXAMINATION PERFORMED ON (B)(6) 2012. AN X-RAY WAS PERFORMED ON THE PT AND DETERMINED THAT THE CAPSULE ENDOSCOPE REMAINED INSIDE THE UPPER SMALL INTESTINE OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ENDOCAPSULE ENDOCAPSULE KOG OLYMPUS MEDICAL SYSTEMS CORPORATION EC-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR