BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 10882159 · Received November 22, 2020

    Report

    Report Number
    8010047-2020-09295
    Event Type
    Malfunction
    Date Received
    November 22, 2020
    Date of Event
    October 28, 2020
    Report Date
    February 17, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170367311
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE A CORRECTION. ADDITIONAL INFORMATION FROM THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST(ESS) STATES THERE WAS NO REPROCESSING DEVIATIONS NOTED ON THE TJF- Q180V. THE REPROCESSING ERRORS WERE REPORTED ON THE FACILITY¿S EUS SCOPE. UPON FURTHER REVIEW, THIS IS NOT A REPORTABLE MALFUNCTION. PER THE LEGAL MANUFACTURER, THERE IS NO POTENTIAL FOR THIS ISSUE TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED. AS PART OF OUR INVESTIGATION, THE PROVIDED A REPROCESSING IN-SERVICE FOR THE TJF-Q180V AND ULTRASOUND GASTROVIDEOSCOPE MODELS THAT INCLUDED ALL PRE-CLEANING, LEAK TESTING, MANUAL CLEANING, DISINFECTION, AND STERILIZATION INFORMATION FROM THE OLYMPUS MANUAL. THE ESS RECOMMENDED THAT CUSTOMER USE THE WASHING TUBE AND CLEANING BRUSH PER THE VALIDATED METHOD. THE ESS REPORTED THAT THE CUSTOMER WILL ORDER THE CLEANING BRUSH. THE ESS SCHEDULED A FOLLOW-UP IN-SERVICE TO THE EDUCATE STAFF ON HOW TO USE WASHING TUBE DURING BEDSIDE CLEANING. THE ESS ALSO PROVIDED INFORMATION REGARDING REPAIR PREVENTION ONLINE TRAINING, ONTRACK FORM AND INFORMATION REGARDING WASHING TUBE AND CLEANING BRUSH TO THE MANAGER.

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT DURING AN ONSITE REPROCESSING IN-SERVICE WITH AN ENDOSCOPY SUPPORT SPECIALIST (ESS), IT WAS NOTED THAT STAFF DID NOT USE WASHING TUBES TO FLUSH EUS ELEVATOR CHANNEL DURING BEDSIDE CLEANING AND DID NOT USE THE CLEANING BRUSH AND SYRINGE TO BRUSH AND FLUSH FORCEPS ELEVATOR DURING MANUAL CLEANING. THE ESS REPORTED THAT THE FACILITY¿S GI TECHNICIANS AND LICENSED PRACTICAL NURSE (LPN) MENTIONED THEY WERE NOT AWARE OF THE CLEANING STEPS USING WASHING TUBE AND CLEANING BRUSH. THERE WAS NO PATIENT INVOLVEMENT, PATIENT INFECTION OR DEVICE POSITIVE CULTURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347248 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V 04953170367311

    Patients

    Seq Age Sex Outcome Treatment
    1