BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 8433990 · Received March 19, 2019

    Report

    Report Number
    2951238-2019-00556
    Event Type
    Injury
    Date Received
    March 19, 2019
    Date of Event
    February 14, 2019
    Report Date
    March 19, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    K024033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT BUT WITH NO RESULT. HOWEVER, ADDITIONAL INFORMATION PROVIDED BY THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) STATES THAT THE USER FACILITY USES ENDOZYME PREMIUM ENZYMATIC CLEANER ON THEIR ENDOSCOPES. THE ENDOSCOPE¿S PRE-CLEANING IS BEING PERFORMED IMMEDIATELY AFTER A PROCEDURE. THE FACILITY WIPES THE ENDOSCOPE DOWN, THEN PERFORMS 30 SECONDS OF SUCTION, AIR WATER CLEANING ADAPTER IS FLUSHED FOR 10 SECONDS WITH FLUID AND 10 SECONDS OF AIR. THE ENDOSCOPE¿S CHANNEL IS BEING BRUSHED DURING MANUAL CLEANING USING A SINGLE USE ENDOCHOICE BRUSH HOG. LEAK TESTING IS PERFORMED WITH AN OLYMPUS MU-1. THE ENDOSCOPE IS THEN PLACED IN THE FACILITY¿S MEDIVATORS DSD EDGE AUTOMATIC ENDOSCOPE PREPROCESSOR (AER). AFTER REPROCESSING THE ENDOSCOPE IS HUNG IN A VENTILATED CABINET AND NO AIR FLUSHED INTO ITS CHANNEL. THE ESS REPORTED THAT THE AER¿S MINIMUM EFFECTIVE CONCENTRATION IS BEING CHECKED AFTER CYCLE. THERE ARE NO ISSUES WITH THE FACILITY¿S AER AT TIMES (THE FACILITY HAS 4 DSD AERS). ADDITIONALLY, THE ESS REPORTED THAT THE FACILITY ¿S LAST REPROCESSING IN-SERVICE WAS PERFORMED IN DECEMBER 2018. THERE HAVE BEEN CHANGES TO THE FACILITY¿S REPROCESSING STAFF SINCE THE LAST IN-SERVICE; HOWEVER, ALL STAFF HAS BEEN TRAINED ON HOW TO REPROCESS AN ENDOSCOPE PROPERLY. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. A REVIEW OF THE INSTRUMENT¿S HISTORY WAS PERFORMED AND REVEALED THAT THE SCOPE WAS PURCHASED ON SEPTEMBER 05, 2006. THERE WERE NO SERVICE/REPAIR RECORDS FOUND SINCE THE DATE OF PURCHASE. THE TJF-106VF REPROCESSING MANUAL WARNS USERS ¿PERFORM A LEAKAGE TEST ON THE ENDOSCOPE AFTER EACH PRECLEANING PROCEDURE. DO NOT USE THE ENDOSCOPE IF A LEAK IS DETECTED. USE OF AN ENDOSCOPE WITH A LEAK MAY CAUSE A SUDDEN LOSS OF THE ENDOSCOPIC IMAGE, DAMAGE TO THE BENDING MECHANISM, OR OTHER MALFUNCTIONS. USE OF A LEAKING ENDOSCOPE MAY ALSO POSE AN INFECTION CONTROL RISK.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT A PATIENT DEVELOPED A LIVER ABSCESS AFTER UNDERGOING A PANCREATIC STENT PROCEDURE. THE PATIENT WAS TRANSFERRED FROM RECOVERY TO ICU. IN ADDITION, THE USER FACILITY REPORTED THAT THE SCOPE USED WAS REINTRODUCED INTO SERVICE (B)(6) 2019. THE SCOPE FAILED LEAK TESTING ON FEBRUARY 16, 2019. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226119 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-160VF

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization