BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 2132248 · Received June 10, 2011

    Report

    Report Number
    8010047-2011-00120
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE USERS EXPERIENCED POOR IMAGE QUALITY IN WHICH THE COLON WALL WAS SAID TO BE INVISIBLE WITHOUT THE IMAGE BEING COMPLETELY LOST. THE INTENDED PROCEDURE WAS SAID TO HAVE BEEN COMPLETED WITH A DIFFERENT BUT SIMILAR OLYMPUS COLONOSCOPE. IT WAS UNKNOWN AT WHAT POINT DURING THE PROCEDURE THE IMAGE QUALITY BECAME POOR. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE USER'S REPORT. THERE WAS NO IMAGE OBSERVED DURING EVALUATION. THERE WERE NO SIGNS OF FLUID INVASION AND THE SUBJECT DEVICE PASSED THE LEAK TEST. THE SOURCE OF THE DIFFICULTY WAS ISOLATED TO THE CHARGE-COUPLE-DEVICE FLEXIBLE PRINTED CIRCUIT (CCD-FPC) UNIT. THE CCD-FPC UNIT WAS REPLACED AND THE DEVICE OPERATED APPROPRIATELY. THE COLONOVIDEOSCOPE WAS SERVICED AND RETURNED TO THE USER FACILITY. 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 DURING AN UNSPECIFIED TYPE OF COLONOSCOPY PROCEDURE, THE USERS EXPERIENCED SIGNIFICANT IMAGE DIFFICULTIES THAT DID NOT ALLOW THEM TO VIEW THE ANATOMICAL STRUCTURES. THE INTENDED PROCEDURE WAS SAID TO HAVE BEEN COMPLETED WITH DIFFERENT BUT SIMILAR ENDOSCOPE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS COLONOSCOPE| LIGHT SOURCE