BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 17436803 · Received August 1, 2023

    Report

    Report Number
    9610595-2023-10942
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    June 27, 2023
    Report Date
    August 31, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170339691
    PMA / PMN Number
    K001241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED TO OLYMPUS FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    CLEANSING AND DISINFECTION WAS DONE USING: CLEANSING: GIOSEPT GIOCHEMICA COMPANY AND BALL BRUSH AORTA COMPANY, CLEANING : GIOMAX GIOCHEMICA COMPANY, DISINFECTION : ISASPOR AND ISACLEAN COMPANY. MINIMUM EFFECTIVE CONCENTRATION WAS CHECKED 2 TIMES A DAY (REPLACED DISINFECTANT). THE AUTOMATIC ENDOSCOPE REPROCESSOR (AERS) USED WERE: PROD. MEDIVATORS INC MOD. MED ISA 6 - ISASPOR SINGLE SHOT SERIAL: (B)(6) PROD. MEDIVATORS INC MOD. MED ISA 6 - ISASPOR SINGLE SHOT SERIAL:(B)(6) PROD. MEDIVATORS INC MOD. MED ISA 6 - ISASPOR SINGLE SHOT SERIAL:(B)(6). THE ENDOSCOPE CHANNEL WAS BRUSHED DURING MANUAL CLEANING USING A DISPOSABLE BRUSH. PRE-CLEANING WAS PERFORMED IMMEDIATELY AFTER A PROCEDURE. PRE-CLEANING WITH PROTEOLYTIC DISINFECTANT AND BALL BRUSH PASS WITH PROTEOLYTIC DISINFECTANT WAS PERFORMED. A LEAK TEST WAS PERFORMED PRIOR TO MANUAL CLEANING USING A OLYMPUS MOD MU-1. THE AER WAS LAST SERVICED: SERIAL: (B)(6) - 30/05/2023, SERIAL: (B)(6) - 30/05/2023, SERIAL: (B)(6) - 25/05/2023. THE ENDOSCOPE IS STORED IN NON-VENTILATED CABINETS. B5: UPDATED CONCOMITANT MEDICAL PRODUCTS: UPDATED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED EVENT WAS NOT CONFIRMED AS THE SCOPE WAS NOT MICROBIOLOGICALLY TESTED BY OLYMPUS. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: "AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. B3 & D8: CORRECTION, B3 AND D8 WERE INADVERTENTLY LEFT OUT OF THE INITIAL REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, DURING REPROCESSING, THE EVIS EXERA II COLONOVIDEOSCOPE BIOPTIC CHANNEL TESTED POSITIVE FOR 55 COLONY FORMING UNITS (CFUS) OF AN UNKNOWN MICROBE. THE DEVICE WAS THEN RETESTED AND HAD A NEGATIVE RESULT. ALL CHANNELS WERE SAMPLED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Description of Event or Problem · 0

    THE NAME OF THE POSITIVE MICROBE IN THE 55/CFU TEST WAS KLEBSIELLA OXYTOCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335361 EVIS EXERA II COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-Q165L 04953170339691

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DISPOSABLE BRUSH: LONG COMPANY HEDGENOG| DISPOSABLE BRUSH: SHORT COMPANY PRINCE MEDICAL