BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA COLONOVIDEOSCOPE

    MDR report key: 17412274 · Received July 28, 2023

    Report

    Report Number
    9610595-2023-10750
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Report Date
    September 19, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE CUSTOMER COMPLETED CLEANING DISINFECTION AND STERILIZATION (CDS) CHECKLIST AND LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE CUSTOMER ANSWERED THE FOLLOWING: - IS THERE ANY (SUSPECTED) PATIENT INFECTION? NO. - HAVE THERE BEEN ANY DEVIATIONS OR DEFICIENCIES OR CONCERNS IN REPROCESSING? NO. - WAS PRECLEANING PERFORMED IMMEDIATELY AFTER PATIENT PROCEDURE? YES. - WAS WATER ASPIRATED THROUGH THE INSTRUMENT/ SUCTION CHANNEL WITH A SUCTION PUMP? YES. - WAS THE AIR/WATER CHANNEL FLUSHED WITH WATER AND AIR BY USING MH-948? YES .- DID THE DEVICE PASS THE LEAK TEST? YES. - PLEASE SPECIFY THE DETERGENT: ENDOZYME .- PLEASE NOTE THE BRUSHED POINTS: INSTRUMENT/ SUCTION CHANNEL, SUCTION CYLINDER, INSTRUMENT. - WERE THERE ANY DEFECTS ON AER / EWD? - WERE ALL CHANNELS CONNECTED WITH CLEANING TUBES WHEN THE ENDOSCOPE WAS SETTING UP INTO THE AER / EWD? YES - WAS THE EXPIRATION DATE OF DISINFECTANT CONTROLLED? YES (BEFORE THE EXPIRATION DATE) - PLEASE SPECIFY HOW WAS IT DRIED: DRY PROCESS OF AER/ EWD. - HOW OR WHERE IS THE ENDOSCOPE BEING STORED AFTER REPROCESSING? DRYING CABINET. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION AND BECAUSE THE USER CULTURE RESULTS WERE NOT SHARED, THE REPORTED EVENT COULD NOT BE CONFIRMED AND 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.

    Additional Manufacturer Narrative · 0

    E1 FACILITY NAME: (B)(6). THE AUTOMATIC ENDOSCOPE REPROCESSOR USED AT THE FACILITY WAS ENDOCLEANSE. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THAT WATER TIGHTNESS WAS LOST DUE TO A PINHOLE ON THE INSTRUMENT TUBE, THE SUCTION CYLINDER WAS SHAVED, THE OBJECTIVE LENS WAS DISCOLORED, AND MULTIPLE PARTS OF THE SCOPE WERE SCRATCHED. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIVING ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE EVIS LUCERA COLONOVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. PSEUDOMONAS AERUGINOSA WAS DETECTED IN REGULAR BACTERIOLOGICAL EXAMINATION. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337148 EVIS LUCERA COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-PQ260L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown