BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 5506114 · Received March 16, 2016

    Report

    Report Number
    2951238-2016-00313
    Event Type
    Malfunction
    Date Received
    March 16, 2016
    Date of Event
    February 19, 2016
    Report Date
    March 1, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    PMA / PMN Number
    PK093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. AS PART OF OUR INVESTIGATION INTO THIS REPORT, OLYMPUS DISPATCHED AN ENDOSCOPY SUPPORT SPECIALIST (ESS) TO THE FACILITY TO OBSERVE THEIR REPROCESSING PRACTICES. ESS VISITED THE FACILITY ON 2/22/2016 TO REVIEW THE REPROCESSING STEPS OF THE GF-UCT180 BASED ON THE REPROCESSING MANUAL. IT WAS IDENTIFIED THAT SCOPE SUCTIONING PROCESS DURING PRE-CLEANING WAS NOT BEING PERFORMED, AND THE PROPER BRUSH FOR CLEANING WAS NOT BEING UTILIZED. ESS RECOMMENDED BOTH STEPS BE IMPLEMENTED AND TO SCHEDULE AN ADDITIONAL IN-SERVICE VISIT IN THE FUTURE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, INSUFFICIENT REPROCESSING COULD BE A CONTRIBUTING FACTOR.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM NWB TO ODG.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT AFTER REPROCESSING THE SCOPE IN A CUSTOM ULTRASONICS AUTOMATED ENDOSCOPE REPROCESSOR (AER), TRACES OF BIO-BURDEN MATERIAL WAS NOTED AT THE DISTAL TIP OF THE DEVICE. THE FACILITY REPORTED THAT THE SCOPE FAILED A CULTURE TEST FOR AN UNSPECIFIED BACTERIA. THE FACILITY PLANS TO HAVE THE SCOPE FURTHER REPROCESSED USING A MEDIVATORS AER. THE SCOPE WILL NOT BE RETURNED FOR FURTHER EVALUATION. THERE'S NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161558 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180

    Patients

    Seq Age Sex Outcome Treatment
    1