BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 16489657 · Received March 6, 2023

    Report

    Report Number
    9610595-2023-03794
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Report Date
    June 15, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    PMA / PMN Number
    K121959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR DEVICE EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, THE EVALUATION FOUND THE FOLLOWING: 10. THE CONNECTING TUBE PROTECTOR WAS FOUND DAMAGED. 2.) THE CONNECTING TUBE WAS SQUEEZED. 3.) THE DRUM UNIT WAS DAMAGED. 4.) THE OUTER CONDITION WAS FOUND TO BE SCRATCHED AND DAMAGED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER REGARDING THE REPORTED EVENT. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: B5, H6 AND INVESTIGATION RESULTS AS FOLLOWS: THE INVESTIGATION COULD NOT CONCLUSIVELY SPECIFY THE ROOT CAUSE OF THE EVENT. REPROCESSING STEPS WERE PROVIDED BY THE USER FACILITY, AND NO OBVIOUS DEVIATIONS FROM THE INSTRUCTIONS FOR USE (IFU) WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND IT WAS CONFIRMED THAT THERE WERE NO MANUFACTURING NON-CONFORMITIES AND THAT THE DEVICE WAS SHIPPED IN ACCORDANCE WITH SPECIFICATIONS. THE IFU STATES THE FOLLOWING IN REGARDS TO PRECAUTIONS IN USING A DEVICE ON A CJF PATIENT: PRIONS, WHICH ARE THE PATHOGENIC AGENTS OF THE CREUTZFELDT-JAKOB DISEASE (CJD) CANNOT BE DESTROYED OR INACTIVATED BY THE REPROCESSING METHODS STATED IN THIS INSTRUCTION MANUAL. WHEN USING THE ENDOSCOPE AND ACCESSORIES ON PATIENTS WITH CJD OR VARIANT CREUTZFELDT-JAKOB DISEASE (VCJD), BE SURE TO USE THEM FOR SUCH PATIENTS ONLY, OR IMMEDIATELY DISPOSE OF THEM AFTER USE IN AN APPROPRIATE MANNER TO PREVENT THE USAGE OF EXPOSED DEVICES ON OTHER PATIENTS. FOR METHODS TO HANDLE CJD, FOLLOW THE RESPECTIVE GUIDELINES IN YOUR COUNTRY.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 0

    THE CUSTOMER PROVIDED ADDITIONAL INFORMATION FROM THE CUSTOMER THAT THE SUPERVISING PHYSICIAN REPORTED THAT FROM THE POINT OF VIEW OF THE NRZ, THERE IS NO EVIDENCE OF A NON-SPORADIC CJD AND IT SPEAK NOTHING AGAINST A REPROCESSING OF THE ENDOSCOPES ACCORDING TO THE APPROPRIATE STANDARD AFTER USE IN CJD PATIENTS.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE FLUID SAMPLE THAT WAS USED TO DETECT PROTEIN 14-3-3 WAS CEREBROSPINAL FLUID. IT WAS ALSO REPORTED THAT NONE OF THE 7 PATIENTS THAT THE SCOPE WAS USED ON HAD SYMPTOMS, NOR WERE THEY TESTED FOR MICROBIAL CONTAMINATION. THE DATE OF THE EXAM/SCOPE USE WAS NO LONGER TRACEABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE CUSTOMER INITIALLY REPORTED TO OLYMPUS AN ISSUE WITH THE SUSPECT DEVICE LEVER AND RETURNED THE DEVICE FOR EVALUATION. THE CUSTOMER INFORMED OLYMPUS THE DEVICE HAD BEEN USED WITH A PATIENT SUSPECTED OF HAVING CJD DURING A (B)(6) 2022 BRONCHOSCOPY FOR AN UNKNOWN INDICATION. BASED ON DOCUMENTS PROVIDED BY THE CUSTOMER, A CSF SPECIMEN WAS SENT TO THE LABORATORY (B)(6) 2022 AND ON (B)(6) 2023, THE PATIENT WAS SUSPECTED OF HAVING CJD BECAUSE OF DETECTION OF PROTEIN 14-3-3; BRAIN HISTOLOGY IS PENDING. THE CUSTOMER INFORMED OLYMPUS THEY SUSPECT THE DEVICE MAY HAVE BEEN CONTAMINATED BY THE PATIENT SUSPECTED OF HAVING CJD AND UNKNOWINGLY USED ON SEVEN (7) ADDITIONAL PATIENTS. THE CUSTOMER STATED THE DEVICE WAS USED DIRECTLY ON THE PATIENT SUSPECTED OF HAVING CJD AND DID NOT SUSPECT THE PATIENT CONTRACTED CJD FROM THE OLYMPUS DEVICE. THEREFORE, IT IS UNLIKELY THE OLYMPUS DEVICE CONTAMINATED THE PATIENT AND THIS EVENT DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY. THE FUC IS A PAE AND THEREFORE REPORTABLE TO THE FDA AS A MALFUNCTION. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531821 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-1TH190

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown