BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GASTROSCOPE

    MDR report key: 15925590 · Received December 6, 2022

    Report

    Report Number
    9610595-2022-04967
    Event Type
    Injury
    Date Received
    December 6, 2022
    Date of Event
    November 3, 2022
    Report Date
    May 3, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THERE WAS NO SPECIFIC MODEL AND SERIAL NUMBER PROVIDED, IT IS UNKNOWN IF THE DEVICE HAS ALREADY BEEN RETURNED TO OLYMPUS FOR EVALUATION OR NOT. HOWEVER, OLYMPUS IS COMMUNICATING WITH THE CUSTOMER TO OBTAIN MORE CLARIFYING INFORMATION REGARDING THE REPORTED EVENT. THE CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THIS REPORT WILL BE UPDATED ACCORDINGLY WHEN NEW AND RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. AS PREVIOUSLY REPORTED, THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE POSITIVE CULTURE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN LESS THAN 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. 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. FURTHERMORE, IT WAS CONFIRMED THAT THE USER DID NOT MAKE ANY OBVIOUS DEVIATIONS FROM THE REPROCESSING STEPS IN THE IFU. 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.¿ THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO B6 TO PROVIDE INFORMATION THAT WAS INADVERTENTLY NOT INCLUDED ON THE PREVIOUS SUBMISSIONS. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO UPDATE THE FOLLOWING SECTIONS: B3, D4-MODEL/SERIAL NUMBER OF THE DEVICE, AND TO LINK THE RELATED COMPLAINT, WHICH C22487852. THIS SECOND COMPLAINT WAS INITIATED TO ACCOUNT FOR THE SECOND PATIENT MENTIONED IN THE REPORT.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE PHYSICAL EVALUATION OF THE DEVICE. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. BASED ON THE EVALUATION PERFORMED, THE DEVICE PASSED ALL FUNCTIONAL TESTS AND INSPECTIONS. NO PROBLEM FOUND WITH THE DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING UPDATED TO REPORT ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER. NEW INFORMATION IS REPORTED IN B5.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED ABOUT A HYGIENE ISSUE AND A MULTI-RESISTANT GERM FOUND IN AN UNIDENTIFIED OLYMPUS GASTROSCOPE. THE CLINIC HAS RECENTLY CONVERTED THE ENTIRE ENDOSCOPE PARK TO OLYMPUS. REPROCESSING IS DONE IN GETTINGE-RDG-E, WHICH WAS NEWLY PURCHASED LAST YEAR. CURRENTLY, THE CLINIC REPORTEDLY HAD AN OUTBREAK OF FOUR MULTI-RESISTANT GRAM NEGATIVE (MRGN) KLEBSIELLA PNEUMONIAE WITH OXA 181 (EMERGING CARBAPENEM-HYDROLYZING OXACILLINASE). THE CUSTOMER HAD DETECTED 80 CFU/10ML OF K.PNEUMONIAE IN THE WATER CHANNEL OF A NEW GASTROSCOPE, AS PART OF THEIR ENDOSCOPE CHECK. THE CARBAPENEMASE RAPID TEST WAS POSITIVE FOR OXA 48. HOWEVER, IT MAY STILL TURN OUT TO BE OXA 181 IN THE NRZ (NITRATE REDUCTASE). THE CUSTOMER FURTHER REPORTED THAT THEY HAD THIS SEVERAL TIMES IN THE OUTBREAK AND THIS GASTROSCOPE WAS USED ON A PATIENT WHO WAS PART OF THE OUTBREAK. ACCORDING TO THE CLINIC, THERE ARE FREQUENT ERROR MESSAGES IN THE RDG-E IN WHICH THE GASTROSCOPE WAS PREPARED.

    Description of Event or Problem · 0

    UPDATE: ADDITIONAL INFORMATION PROVIDED BY THE PHYSICIAN: CLARIFICATION/SEQUENCE OF EVENTS: ONE PATIENT WHO WAS INFECTED WITH THE HOSPITAL PATHOGEN WAS EXAMINED WITH THE OLYMPUS ENDOSCOPE. AFTER THAT SEVEN ADDITIONAL PATIENTS WERE EXAMINED WITH THE ENDOSCOPE UNTIL THE DEVICE WAS SAMPLED BY THE LAGUS AND THE GERMS WERE DETECTED ON THE DEVICE/THE DEVICE WAS TAKEN IN QUARANTINE. THE DEVICE WAS THEN SENT TO OLYMPUS FOR HMI/REPAIR AND NO GERMS WERE FOUND DURING HMI. BETWEEN THE PATIENTS THE REPROCESSING WAS OF COURSE CARRIED OUT COMPLETELY IN EACH CASE NONE OF THE SEVEN EXAMINED PATIENTS SO FAR HAVE AN INFECTION THAT COULD BE DETECTED WITH THE SAME MICROORGANISM. NEVERTHELESS, THE PATIENTS WERE "MARKED" AS POTENTIALLY BEING AT RISK AND WILL BE EXAMINED AGAIN - IF APPLICABLE. IN SUMMARY: THERE IS CURRENTLY ONLY A RISK POTENTIAL FOR THE PATIENTS AND NO PROVEN INFECTION HAS OCCURRED DUE TO THE CONTAMINATION OF THE OLYMPUS ENDOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308305 GASTROSCOPE UNKNOWN FDS AIZU OLYMPUS CO., LTD. GIF-1100 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown