BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS COLONOSCOPE

    MDR report key: 2470600 · Received February 17, 2012

    Report

    Report Number
    8010047-2012-00038
    Event Type
    Injury
    Date Received
    February 17, 2012
    Report Date
    January 20, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS (B)(4) INC. (OCI) REPRESENTATIVE VISITED THE USER FACILITY ON (B)(4) 2012 AND WAS INFORMED THAT THE USER DID NOT ALLEGE THE COLONOSCOPE TO BE THE CAUSE OF THE PT'S OUTCOME. THE EXACT DATES OF THE REPORTED EVENTS WERE NOT REPORTED. ALL THREE PTS WERE EXAMINED BY THREE DIFFERENT PHYSICIANS IN THREE DIFFERENT ROOMS AND USED THREE DIFFERENT COLONOSCOPES BUT THE USER FACILITY DID NOT PROVIDE THE SPECIFIC MODEL AND SERIAL NUMBERS OF THE DEVICES. ALL THREE PTS REQUIRED ADDITIONAL SURGICAL INTERVENTION TO TREAT THE BOWEL PERFORATION. THERE WERE NO DEVICES RETURNED TO OLYMPUS FOR EVALUATION. THE CURRENT CONDITION OF THE PTS IS UNK. THE EXACT CAUSE OF THE PT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFO IS RECEIVED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS ONE OF THREE REPORTS. CROSS REFERENCE MFR REPORT NUMBER 8010047-2012-00036 AND 8010047-2012-00037.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEY EXPERIENCED THREE SEPARATE BOWEL PERFORATIONS SOMETIME IN THE THREE WEEKS PERIOD LEADING UP TO (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1