BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS

    MDR report key: 1770348 · Received July 20, 2010

    Report

    Report Number
    8010047-2010-00140
    Event Type
    Other
    Date Received
    July 20, 2010
    Date of Event
    June 5, 2010
    Report Date
    June 21, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP ON THIS REPORT TO GATHER ADDITIONAL INFO. OLYMPUS WAS INFORMED THAT THE PHYSICIAN HAD INITIALLY BELIEVED THE FRAGMENT TO BE A WASHER, HOWEVER, THEY LATER NOTED THAT A PORTION OF THE BIOPSY COVER WAS MISSING. THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVAL. IF THE PRODUCT IS RECEIVED, OR IF ADDITIONAL SIGNIFICANT INFO IS PROVIDED, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS MDR IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN UNK TYPE OF COLONOSCOPY PROCEDURE, A PORTION OF AN OLYMPUS REUSABLE BIOPSY PORT COVER HAD BEEN PUSHED INTO THE INSTRUMENT CHANNEL AND FALLEN INTO THE PT'S COLON. THE PHYSICIAN OBSERVED THE ITEM IN THE PT'S COLON DURING THE SAME PROCEDURE, AND USED A FORCEPS TO SUCCESSFULLY RECOVER THE PORTION OF THE DEVICE. THERE WAS NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SEMI-DISPOSABLE BIOPSY VALVE KNW OLYMPUS MEDICAL SYSTEMS CORP. MB-358 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MODEL COLONOSCOPE