BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA COLONOVIDEOSCOPE

    MDR report key: 2072612 · Received April 22, 2011

    Report

    Report Number
    8010047-2011-00084
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 25, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORT, AND WAS INFORMED THAT THE WATER PRESSURE COMING OUT FROM THE AUXILIARY WATER CHANNEL OF THE SCOPE WAS TOO STRONG. THE USERS ALLEGED THAT THE STRONG WATER PRESSURE CAUSED THE PT'S OUTCOME. HOWEVER, THE USER FACILITY REPORTED THAT THE PT DID NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION. THE PT WAS DISCHARGED FROM THE USER FACILITY THE SAME DAY OF THE PROCEDURE. AS PART OF OUR INVESTIGATION INTO THIS REPORT, A FIELD SERVICE ENGINEER, ENDOSCOPY SUPPORT SPECIALIST AND SALES REP VISITED THE USER FACILITY TO ADDRESS THE USER'S REPORT AND TO REASSESS THE USERS PRACTICES. BASED ON THIS VISIT, OLYMPUS PERSONNEL NOTED THAT THE USERS WERE USING A NON-OLYMPUS TUBING IN CONJUNCTION WITH THE OLYMPUS FLUSHING PUMP, AND CONFIRMED THAT THE WATER PRESSURE COMING OUT FROM THE COLONOSCOPE WAS STRONG. OLYMPUS PERSONNEL ADVISED USERS OF THE CORRECT CONFIGURATION WHEN USING THE OLYMPUS FLUSHING PUMP AND THE COLONOSCOPE. THE SUBJECT COLONOSCOPE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL CONFIRMED THAT THE AUXILIARY WATER CHANNEL WAS KINKED AND DAMAGED, WHICH LIKELY CAUSED THE USER'S EXPERIENCE. THE COLONOSCOPE WAS SERVICED AND WAS RETURNED TO THE USER FACILITY. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. THIS IS 1 OF 2 REPORT. CROSS REFERENCE MFR REPORT # 8010047-2011-00085 FOR RELATED REPORT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED DURING A COLONOSCOPY, THE "WATER CHANNEL WAS BACKED UP CAUSING A LOT OF PRESSURE AND WHEN THE WATER LINE DOES NOT WORK, IT IS CAUSING TEARING IN THE COLON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA COLONOVIDEOSCOPE CONOLOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEM CORPORATION CF-H180AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS FLUSHING PUMP: MODEL OFP,| SERIAL # (B)(4)