BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 16894834 · Received May 9, 2023

    Report

    Report Number
    9610595-2023-07237
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Date of Event
    April 20, 2023
    Report Date
    August 9, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305191
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S (LM) FINAL INVESTIGATION. THE E1 "TELEPHONE NUMBER" FIELD WAS CORRECTED BASED ON INFORMATION AVAILABLE AT THE INITIAL REPORT SUBMISSION. 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. GROWTH OF MICROORGANISMS WERE REPORTED THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. 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

    THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) WAS PERFORMED BY THE CUSTOMER. THERE WAS NO PATIENT INFECTION. PRE-CLEANING INVOLVED ASPIRATION OF WATER THROUGH THE INSTRUMENT/SUCTION CHANNEL AND FLUSHING OF THE AIR/WATER AND AUXILIARY CHANNELS. SEKUSEPT WAS USED AS THE DETERGENT FOR MANUAL CLEANING. MANUAL CLEANING INVOLVED BRUSHING THE INSTRUMENT/SUCTION CHANNEL, SUCTION CYLINDER, AND INSTRUMENT CHANNEL PORT. A DUXORED REF EB 1-D01-50 BRUSH WAS USED DURING MANUAL CLEANING. SEKUSEPT WAS USED FOR MANUAL DISINFECTION. A WASSENBURG WD 440 ENDOSCOPE WASHER WAS USED WITH ENDOHIGH DETERGENT AND ENDOHIGH PAA DISINFECTANT. THE SCOPE WAS STORED IN A WASSENBURG DRY 320 STORAGE CABINET. OLYMPUS WAS USED FOR MAINTENANCE AND REPAIR. AFTER THE DEVICE WAS RETURNED TO OLYMPUS, IT WAS SENT OUT FOR ADDITIONAL TESTING. THE MICROBIOLOGICAL ANALYSIS REPORT INDICATED THE CHANNELS OF THE SCOPE WERE CULTURED AND THE RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL FOR AN ENDOSCOPE SUBJECTED TO HIGH LEVEL DISINFECTION AND RINSED WITH STERILE WATER. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THAT WATER TIGHTNESS WAS LOST DUE TO A PINHOLE ON THE INSTRUMENT TUBE, THE INSULATION RESISTANCE VALUE AT THE DISTAL END DID NOT MEET THE STANDARD VALUE DUE TO A CRACK ON THE SCOPE COVER, THE ADHESIVE AROUND THE OBJECTIVE LENS HAD A PINHOLE, THE ADHESIVE AROUND THE LIGHT GUIDE LENS WAS CRACKED, THE LIGHT GUIDE LENS WAS CRACKED, THE BENDING SECTION COVER ADHESIVE WAS DETACHED, THE BENDING ANGLE IN THE UP DIRECTION DID NOT MEET THE STANDARD VALUE DUE TO WEAR OF THE ANGLE WIRE, THE UNIVERSAL CORD WAS BUCKLED, THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIVING ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    SUPPLEMENTAL INFORMATION: THE CUSTOMER CONFIRMED THE DEVICE WAS NOT USED IN A PROCEDURE AFTER THE POSITIVE CULTURE TEST WAS CONFIRMED. THE CUSTOMER HAS NOT PROVIDED HMI RESULTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE EVIS EXERA III COLONOVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877324 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H190L 04953170305191

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown