BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 7924721 · Received October 1, 2018

    Report

    Report Number
    2951238-2018-00589
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Report Date
    March 1, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION FROM THE ESS. AS PART OF OUR INVESTIGATION OF THIS REPORT, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO THE USER FACILITY TO ASSESS THEIR REPROCESSING PRACTICES AND TO PROVIDE REPROCESSING TRAINING IF NECESSARY. THE CUSTOMER DECLINED THE ESS VISIT.

    Additional Manufacturer Narrative · 1

    THE MEDWATCH REPORT PROVIDED AN INCORRECT SERIAL NUMBER FOR THE MODEL GF-UCT180 SCOPE; THEREFORE, IT IS UNKNOWN IF THE DEVICE WAS RETURNED OLYMPUS FOR EVALUATION AND/ OR SERVICE. OLYMPUS WILL CONTINUE TO INVESTIGATE THIS COMPLAINT TO OBTAIN MORE DETAILED INFORMATION REGARDING THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH REPORT WHICH STATES THAT DURING ROUTINE CULTURING THE SCOPE TESTED POSITIVE FOR POSITIVE FOR A CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE). ACCORDING TO THE REPORT, THE SCOPE LAST CULTURED NEGATIVE ON (B)(6) 2018. THE SCOPE HAS BEEN USED 11 TIMES BETWEEN (B)(6) AND (B)(6). THE SCOPE WAS REPORTEDLY RETURNED TO THE MANUFACTURER FOR REPAIR ON APRIL 19, 2018 AND WAS NOT UTILIZED AGAIN UP TO THE TIME OF THE ROUTINE SCOPE CULTURING. THERE WERE NO ASSOCIATED PATIENT INFECTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764975 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180

    Patients

    Seq Age Sex Outcome Treatment
    1