BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINO-LARYNGO VIDEOSCOPE

    MDR report key: 15237352 · Received August 16, 2022

    Report

    Report Number
    3002808148-2022-01070
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Report Date
    September 20, 2022
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    EOB
    UDI-DI
    04953170291050
    PMA / PMN Number
    K061313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE NAME AND COMPLETE ADDRESS OF THE USER FACILITY WAS NOT PROVIDED. NO CONTACT INFORMATION WAS PROVIDED FOR THE USER FACILITY. IMPROVEMENT MEASURES ARE UNDER CONSIDERATION. THIS REPORT WILL BE SUPPLEMENTED WHEN NEW INFORMATION BECOMES AVAILABLE LATER.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE REPORTED EVENT OCCURRED DUE TO HUMAN ERROR. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: ¿WARNINGS AND CAUTIONS: BEFORE USING THIS INSTRUMENT FOR THE FIRST TIME, REPROCESS IT ACCORDING TO THE INSTRUCTIONS GIVEN IN ¿REPROCESSING: GENERAL POLICY¿ THROUGH ¿CLEANING, DISINFECTION, AND STERILIZATION PROCEDURE¿. IMPROPER AND/OR INCOMPLETE REPROCESSING OR STORAGE CAN PRESENT AN INFECTION-CONTROL RISK.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THIS MEDICAL SAFETY INFORMATION IS BASED ON CASES COLLECTED IN THE MEDICAL ACCIDENT INFORMATION COLLECTION PROJECT (A PROJECT SUBSIDIZED BY THE MINISTRY OF HEALTH, LABOR AND WELFARE), AND WAS PREPARED TO PREVENT MEDICAL ACCIDENTS FROM OCCURRING AND RECURRING. UPON REVIEW OF THE MED-SAFE REPORT NO. 185, OLYMPUS FOUND THE 39TH QUARTERLY REPORT WHICH CONTAINED REPORTS RELATED TO ENDOSCOPE CLEANING/DISINFECTION. THERE WERE 14 EVENTS OR REPORTS RELATED TO CLEANING/DISINFECTION OF ENDOSCOPES FOUND IN THE 39TH QUARTERLY REPORT. THE COLLECTION PROJECT WAS SAID TO HAVE STARTED FROM OCTOBER 2004, AND UP TO THE ANALYSIS PERIOD COVERED BY THIS REPORT FROM JULY-SEPTEMBER 2014. THIS IS 4 OF 14 REPORTED EVENTS. THE ARTICLE REPORTED THAT ¿DOCTOR A PERFORMED NASAL FIBER ON PATIENT B DURING OUTPATIENT FOLLOW-UP OF OROPHARYNGEAL CANCER. BEFORE THE PROCEDURE, DOCTOR A USED THE FIBER TO TALK TO NURSE C, AND NURSE C PREPARED THE FIBER AND WROTE THE NAME OF PATIENT B IN THE WASH LIST (THE WASHING LIST IS WHAT IS WRITTEN WHEN CLEANING USING THE FIBER, AND THE PATIENT'S NAME, THE DOCTOR USED, THE WASHING START TIME, AND THE NAME OF THE NURSE IN CHARGE ARE WRITTEN). AFTER THAT, NURSE C DID NOT NOTICE THAT THE FIBER HAD ENDED, AS SHE WAS ALSO DEALING WITH OTHER PATIENTS AND HAD NOT BEEN INFORMED BY DOCTOR A THAT THE FIBER HAD ENDED. DOCTOR D THEN PERFORMED NASAL FIBER ON PATIENT E. THERE WAS NO TALK TO THE NURSE BEFORE THE IMPLEMENTATION. AFTER THE PROCEDURE, OTHER NURSES WERE CONTACTED AND TRIED TO PERFORM FIBER CLEANING, BUT ALTHOUGH THERE WAS A DESCRIPTION OF PATIENT B IN THE WASH LIST, THERE WAS NO DESCRIPTION OF THE WASHING START TIME, AND IT WAS CONFIRMED BY THE DESCRIBED NURSE C, WHERE AFTER USING PATIENT B, IT WAS NOTICED THAT IT WAS USED BY PATIENT E WITHOUT WASHING. WHEN I ASKED DOCTOR D IF THERE WAS A "FINISHED CLEANING" TAG ON THE FIBER BEFORE USE, HE SAID THERE WAS NONE. AS A RESULT OF THE BLOOD COLLECTION OF PATIENT B, IT WAS FOUND THAT THE INFECTION WAS NEGATIVE, AND IT WAS FOUND THAT THERE WAS NO FEAR OF INFECTION IN PATIENT E.¿ BASED ON THE ARTICLE, THE FIBERSCOPE WAS USED ON ANOTHER PATIENT (PATIENT E) WITHOUT A TAG THAT INDICATES THAT THE FIBERSCOPE HAS BEEN CLEANED. IT WAS ALSO STATED THAT UNCLEAN ENDOSCOPE AND CLEAN ENDOSCOPES WERE BEING STORED IN THE SAME PLACE. NO PATIENT INFECTION OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1916067 RHINO-LARYNGO VIDEOSCOPE RHINO-LARYNGO VIDEOSCOPE EOB SHIRAKAWA OLYMPUS CO., LTD. ENF-VQ 04953170291050

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male