BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA GASTROVIDEOSCOPE

    MDR report key: 1931771 · Received December 8, 2010

    Report

    Report Number
    8010047-2010-00247
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 12, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFO REGARDING THE REPORT, BUT NO FURTHER INFO WAS PROVIDED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE INTERNAL CHANNELS OF THE GASTROSCOPE WERE EXAMINED AND NO ANOMALIES WERE DETECTED. THE DEVICE PASSED THE LEAK TESTING, AND SUCTION FLOW WAS WITHIN SPECIFICATIONS. THE BENDING SECTION COVER GLUE WAS SCRATCHED, CRACKED AND PEELING. THE DEVICE WAS SERVICED AND RETURNED TO THE USER FACILITY. IN ADDITION, AN OLYMPUS ENDOSCOPE SERVICE SPECIALIST HAD BEEN DISPATCHED TO THE USER FACILITY TO ASSESS THE USER FACILITY'S REPROCESSING PRACTICES AND TO PROVIDE IN-SERVICE TRAINING REGARDING REPROCESSING AS NEEDED. IF SIGNIFICANT ADDITIONAL INFO BECOMES AVAILABLE AT A LATER DATE, THE REPORT WILL BE UPDATED. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER, INSUFFICIENT REPROCESSING LIKELY CONTRIBUTED TO THE REPORTED EVENT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH NO HOMEOSTASIS CLIPS WERE SAID TO HAVE BEEN USED, THE USERS EXPERIENCED DIFFICULTY WITH SUCTION, AND A CLIP WAS DISLODGED INTO THE PT. THE CLIP WAS REMOVED BY UNSPECIFIED MEANS, AND THERE WAS NO PT INJURY REPORTED. THE USER FACILITY REPORTED THAT THE ENDOSCOPE HAD BEEN USED IN A PROCEDURE IN WHICH CLIPS HAD BEEN USED A FEW DAYS PREVIOUSLY, AND REPROCESSED SEVERAL TIMES BETWEEN PRIOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA GASTROVIDEOSCOPE GASTROSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORPORATION GIF-XTQ160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1