BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 18814948 · Received March 1, 2024

    Report

    Report Number
    9610595-2024-04334
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    January 4, 2024
    Report Date
    April 4, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    PMA / PMN Number
    K024033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS. (B)(6); (B)(6). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURE'S (LM) REVIEW OF THE STUDY PROVIDED REPROCESSING STEPS AND THE LMS FINAL INVESTIGATION. THE LM REVIEWED THE REPROCESSING STEPS DESCRIBED IN THE STUDY WHERE INFORMATION TO JUDGE DEVIATION FROM THE INSTRUCTIONS FOR USE (IFU) WAS NOT IDENTIFIED. 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 SUBJECT DEVICE WAS NOT RETURNED, THE REPORTED EVENT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: "FAILURE TO PROPERLY CLEAN AND HIGH-LEVEL DISINFECT OR STERILIZE ENDOSCOPIC EQUIPMENT AFTER EACH PROCEDURE CAN COMPROMISE PATIENT SAFETY. TO MINIMIZE THE RISK OF TRANSMITTING DISEASES FROM ONE PATIENT TO ANOTHER, AFTER EACH PROCEDURE THE ENDOSCOPE AND ITS ANCILLARY EQUIPMENT MUST UNDERGO THOROUGH MANUAL CLEANING FOLLOWED BY HIGH-LEVEL DISINFECTION OR STERILIZATION AS DESCRIBED IN CHAPTER 3, ¿CLEANING, DISINFECTION AND STERILIZATION PROCEDURES¿. REPROCESS NOT ONLY THE EXTERNAL SURFACE OF THE ENDOSCOPE BUT ALSO ALL CHANNELS.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "UNVEILING 8 YEARS OF DUODENOSCOPE CONTAMINATION: INSIGHTS FROM A RETROSPECTIVE ANALYSIS IN A LARGE TERTIARY CARE HOSPITAL". LITERATURE SUMMARY. OBJECTIVE . CONTAMINATED DUODENOSCOPES CAUSED SEVERAL HOSPITAL OUTBREAKS. DESPITE EFFORTS TO REDUCE CONTAMINATION RATES, 15% OF PATIENT-READY DUODENOSCOPES ARE STILL CONTAMINATED WITH GASTROINTESTINAL MICROORGANISMS. THIS STUDY AIMED TO PROVIDE AN OVERVIEW OF DUODENOSCOPE CONTAMINATION OVER TIME, IDENTIFY RISK FACTORS AND STUDY THE EFFECTS OF IMPLEMENTED INTERVENTIONS. DESIGN. DUODENOSCOPE CULTURE SETS BETWEEN MARCH 2015 AND JUNE 2022 AT A DUTCH TERTIARY CARE CENTRE WERE ANALYSED. CONTAMINATION WAS DEFINED AS (1) THE PRESENCE OF MICROORGANISMS OF ORAL OR GASTROINTESTINAL ORIGIN (MGO) OR (2) ANY OTHER MICROORGANISM WITH =20 COLONY-FORMING UNITS/20 ML (AM20). A LOGISTIC MIXED EFFECTS MODEL WAS USED TO IDENTIFY RISK FACTORS AND ASSESS THE EFFECT OF INTERVENTIONS, SUCH AS USING DUODENOSCOPES WITH DISPOSABLE CAPS, REPLACING AUTOMATED ENDOSCOPE REPROCESSORS (AER) AND CONDUCTING AUDITS IN THE ENDOSCOPY DEPARTMENT. RESULTS. A TOTAL OF 404 CULTURE SETS WERE ANALYSED. THE YEARLY CONTAMINATION RATE WITH MGO SHOWED GREAT VARIATION, RANGING FROM 14.3% TO 47.5%. CONTAMINATION WITH AM20 INCREASED UP TO 94.7% BY 2022. FOR BOTH MGO AND AM20, THE BIOPSY AND SUCTION CHANNELS WERE THE MOST FREQUENTLY CONTAMINATED DUODENOSCOPE COMPONENTS. THE STUDIED INTERVENTIONS, INCLUDING AUDITS, AER REPLACEMENT AND IMPLEMENTATION OF DUODENOSCOPES WITH DISPOSABLE CAPS, DID NOT SHOW A CLEAR ASSOCIATION WITH CONTAMINATION RATES. CONCLUSION. DUODENOSCOPE CONTAMINATION REMAINS A SIGNIFICANT PROBLEM, WITH HIGH CONTAMINATION RATES DESPITE SEVERAL INTERVENTIONS. REPROCESSING THE BIOPSY AND SUCTION CHANNELS IS ESPECIALLY CHALLENGING. CHANGES IN THE DESIGN OF REUSABLE DUODENOSCOPES, SUCH AS ENABLING STERILISATION OR EASILY REPLACEABLE CHANNELS, ARE NECESSARY TO FACILITATE EFFECTIVE DUODENOSCOPE REPROCESSING AND TO ELIMINATE THE RISK OF DUODENOSCOPE-ASSOCIATED INFECTIONS. EVENT. CONTAMINATION WITH MGO, CONTAMINATION WITH AM20: A TOTAL OF 114 CULTURE SETS WERE COLLECTED, OF WHICH 24 (21%) WERE CONTAMINATED WITH MGO AND 9 (7.9%) WERE CONTAMINATED WITH AM20 (TABLE 1 OF THE ARTICLE). ALL THREE DUODENOSCOPES WERE CONTAMINATED ACCORDING TO EITHER DEFINITION (MGO/AM20) AT SOME POINT IN THE STUDY. THERE WAS NO EVIDENCE THAT THE CONTAMINATION OF THE DUODENOSCOPES LED TO ADVERSE EVENTS IN PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310287 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-160VR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DUODENOVIDEOSCOPE TJF-160VR, SN- (B)(6).| DUODENOVIDEOSCOPE TJF-160VR, SN- (B)(6).