BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 16916041 · Received May 11, 2023

    Report

    Report Number
    9610595-2023-07370
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    April 11, 2023
    Report Date
    July 12, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170202506
    PMA / PMN Number
    K100584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) RESULTS WERE PROVIDED. THE RESULTS REPORTED THE DEVICE TESTED POSITIVE WITH THE FOLLOWING: SAMPLING DATE: (B)(6) 2023. KLEBSIELLA PNEUMONIAE - NO CFU (NUMBER OF COLONY FORMING UNIT (FCU) NOT PROVIDED. PSEUDOMONAS AERUGINOSA - NO CFU (NUMBER OF COLONY FORMING UNIT (FCU) NOT PROVIDED. THE OLYMPUS SUBSIDIARY FOR HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) PERFORMED A CULTURE TEST FOR THE DEVICE AFTER THE DEVICE WAS REPROCESSED. THE RESULTS REPORTED DEVICE CHANNEL (ALL CHANNELS) CONFORMS TO RESULTS OF 1 CFU/100 ML AND 1 CFU/ENDOSCOPE= UNTARGETED IDENTIFICATION -GRAM POSITIVE BACTERIA-DETECTED (BACILLI). THE RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL DEFINED IN THE INSTRUCTION DGOS/PF2/DGS/VSS1/2016/220 OF (B)(6) 2016. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    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. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH 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

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON DEVICE RETURN EVALUATION AT OLYMPUS REGIONAL REPAIR CENTER (RRC). ADDITIONALLY, THIS SUPPLEMENTAL REPORT IS TO INFORM THAT THE TOTAL GERMS REPORTED ON THE HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) RESULTS PROVIDED BY THE CUSTOMER NOTED TO BE 26 CFU/100 ML AT 30 DEGREES CELSIUS/5 DAYS R2A MEDIUM SUBCONTRACTING/SAMPLING TEST. DEVICE EVALUATION OF THE OLYMPUS REGIONAL REPAIR CENTER (RRC) , THE FOLLOWING FINDINGS WERE IDENTIFIED. INSULATION TEST FAILED ON THE INSERTION PART DISTAL END (C-COVER), DISTAL END C-COVER NOTED TO BE CRACKED. LIGHT GUIDE COVER LENS FOUND CRACKED. BENDING SECTION (A-RUBBER) GLUE NOTED TO BE SEPARATED. CONNECTING TUBE WRINKLE 10 MM FROM GLUE. UNIVERSAL CORD NOTED WRINKLE. ANGULATION TEST FAILED ( CONTROL UNIT, RIGHT /LEFT KNOB, UP/DOWN KNOB). INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    CUSTOMER SENT A REPAIR REQUEST REPORTED WITH ISSUE OF "CONTAMINATION". PER THE REPORT , NO PATIENT INJURY WAS NOTIFIED BY THE CUSTOMER. NO REPORT OF ANY CONTAMINATION OR ANY PATIENT INJURY OR PATIENT INFECTION TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602757 EVIS EXERA II COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H180AI 04953170202506

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown