BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 13014702 · Received December 15, 2021

    Report

    Report Number
    8010047-2021-16201
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Report Date
    June 16, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170356346
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO G2. G2 - CHECKED "OTHER" TO ADD THE COUNTRY BELGIUM. THREE ATTEMPTS WERE PERFORMED TO OBTAIN THE CLEANING, DISINFECTION, AND STERILIZATION OF THE SCOPE INSTRUCTIONS BUT WERE NOT SUCCESSFUL. IF ADDITIONAL INFORMATION IS OBTAINED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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, IT IS UNLIKELY THE POSITIVE CULTURE WAS CAUSED BY THE DEVICE. 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), THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. THIS INFORMATION IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): "WARNING: THOROUGHLY CLEAN AND HIGH-LEVEL DISINFECT OR STERILIZE THE ENDOSCOPE BEFORE RETURNING IT FOR REPAIR. IMPROPERLY REPROCESSED EQUIPMENT POSES AN INFECTION CONTROL RISK TO EACH PERSON WHO HANDLES THE ENDOSCOPE WITHIN THE HOSPITAL OR AT OLYMPUS." OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CULTURE RESULTS REPORTED THE DEVICE TESTED POSITIVE WITH THE PRESENCE OF INDICATOR ORGANISM AS PROVIDED BELOW : CULTURE TEST RESULTED AT GREATER THAN 20 CFU/ORGANISMS. KLEBSIELLA PNEUMONIAE 21/22 CFU ACINETOBACTER LACTUCAE 23/24 CFU STAPHYLOCCOCUS EPIDERMIS 25 CFU (B)(4) OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL DEFINED IN THE REGULATIONS OF FRANCE OUTLINED ON JULY 4, 2016. THE RESULTS ARE CONFORM TO FRENCH RECOMMENDATION. RESULTS: MICRO-ORGANISMES REVIVIFIABLES 3 CFU GRAM POSITIVE BACTERIA DETECTED COAGULASE NEGATIVE STAPHYLOCOCCI DETECTED (B)(4) RRC WILL PROCEED WITH A NORMAL REPAIR IF NECESSARY. THE CUSTOMER CDS CHECKLIST HAS NOT YET BEEN RECEIVED. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    AS REPORTED, AFTER A SECOND CHECK THE CULTURE ON THE ULTRASOUND ENDOSCOPE 792336 IS STILL POSITIVE WITH THE PRESENCE OF INDICATOR ORGANISM. THE NUMBER OF CFU IS GREATER THAN 20 AND SHOULD NOT EXCEED 1 CFU DURING A SECOND CHECK FOR HIGH-RISK ORGANISMS. THE DEVICE WAS PLACED IN QUARANTINE. THE USER THEN SENT THE DEVICE TO THE (B)(4) OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) FOR FURTHER INVESTIGATION. THE USER DID NOT REPORT 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
    1911860 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170356346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown