BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 2240852 · Received August 4, 2011

    Report

    Report Number
    8010047-2011-00180
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY VIA PHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE USER'S REPORT. THE EVALUATION FOUND THE DISTAL-END COVER BURNT AND CHIPPED, AND THE DISTAL END OPENING OF THE INSTRUMENT CHANNEL WAS DAMAGED AND WAS SHARP, WHICH COULD ATTRIBUTED TO THE REPORTED PHENOMENON. THE INTERIOR OF THE INSTRUMENT CHANNEL OPENING WAS NOTED WITH JAGGED SHARP EDGES WHICH CAUSED RESTRICTION FOR INSTRUMENTS. 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 ESOPHAGOGASTRIC DUODENOSCOPY (EGD) WITH DILATION PROCEDURE, WHEN THE USERS PUT THE DILATOR IN FOR PROCEDURE, THE BALLOON BURST WHEN EXPANDED TWICE. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS GASTROINTESTINAL VIDEOSCOPE GASTROSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORPORATION GIF-XQ140 NA

    Patients

    Seq Age Sex Outcome Treatment
    1