BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 6197168 · Received December 21, 2016

    Report

    Report Number
    2951238-2016-00967
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Report Date
    March 3, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM FDF TO FDS AND 510(K) NUMBER.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION WAS UNABLE TO CONFIRM THE REPORTED EVENT. THE EVALUATION FOUND THE BENDING SECTION RUBBER GLUE CRACKED; HOWEVER, THERE WAS NO DEVICE FRAGMENT MISSING FROM THE SCOPE. THE SOURCE OF THE FOREIGN OBJECT COULD NOT BE DETERMINED. THE DEVICE WAS SERVICED AND RETURNED TO THE USER FACILITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AS THERE ARE WAS NO MISSING FRAGMENTS FOUND WITHIN THE SCOPE; HOWEVER, THE MOST PROBABLE CAUSE COULD BE ATTRIBUTED TO INSUFFICIENT BRUSHING OF THE CHANNELS DURING REPROCESSING. THE REPROCESSING INSTRUCTION MANUAL STATES, ¿BE SURE TO THOROUGHLY BRUSH THE INSIDE OF THE INSTRUMENT CHANNEL, THE INSTRUMENT CHANNEL PORT, THE SUCTION CHANNEL, AND THE SUCTION CYLINDER OF THE ENDOSCOPE. INSUFFICIENT BRUSHING MAY POSE AN INFECTION CONTROL RISK.¿

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A DIAGNOSTIC GASTROSCOPY PROCEDURE, A BLACK PIECE OF FOREIGN OBJECT MEASURING APPROXIMATELY 1 INCH LONG CAME OUT OF THE SCOPE AND FELL INSIDE THE PATIENT. THE FOREIGN OBJECT WAS RETRIEVED. NO X-RAY WAS NEEDED AND THE PROCEDURE WAS COMPLETED USING THE SAME SCOPE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845442 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-HQ190 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1