BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 11237069 · Received January 27, 2021

    Report

    Report Number
    8010047-2021-01927
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    December 28, 2020
    Report Date
    January 27, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170305290
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE REPORTABILITY CORRECTION. MFR. REPORT NUMBER: 8010047-2021-01927 IS A DUPLICATE REPORT. PLEASE REFERENCE MFR. REPORT NUMBER: 8010047-2021-00962 FOR ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE LOANER SCOPE WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION. THE SCOPE WAS EVALUATED BY THE ESTIMATION TEAM AND NO ABNORMALITIES WERE OBSERVED WITH THE SCOPE. THE SCOPE WAS RETURNED TO THE SERVICE CENTER'S INVENTORY AS AN ASSET. IN ADDITION, 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. TO DATE, THE ESS VISIT HAS NOT BEEN FINALIZED. THE INVESTIGATION IS ONGOING AND IF ADDITIONAL INFORMATION IS RECEIVED THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A SCOPE WAS USED IN AN UNSPECIFIED PROCEDURE, ON A PATIENT WITH KLEBSIELLA OXYTOCA CARBAPENEM (KCP) RESISTANT ORGANISMS. ON (B)(6) 2020, THE SCOPE WAS CULTURED AND RESULTS SHOWED 40 COLONIES OF KLEBSIELLA AEROGENES. THE SCOPE WAS RE-CULTURED ON (B)(6) 2020, AND TESTED POSITIVE FOR 12 CFU'S OF KLEBSIELLA (ENTEROBACTER) AEROGENES. THE FACILITY REPORTED THAT EACH TIME THE SCOPE WAS REPROCESSED PRIOR TO SAMPLES BEING TAKEN USING THE FLUSH AND BRUSH CULTURE METHOD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133083 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H190 04953170305290

    Patients

    Seq Age Sex Outcome Treatment
    1