BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 20345353 · Received October 1, 2024

    Report

    Report Number
    9610595-2024-19697
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    July 21, 2024
    Report Date
    December 23, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170405563
    PMA / PMN Number
    K220587
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S (LM) FINAL INVESTIGATION AND REVIEW OF THE CUSTOMER CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES. ADDITIONALLY, TO PROVIDE A CORRECTION TO FIELD A2 AND TO PROVIDE AN UPDATE TO FIELD D8. THE LM REVIEWED THE CUSTOMERS PROVIDED THE CDS PROCESSES WHERE NO OBVIOUS DEVIATIONS FROM THE INSTRUCTION FOR USE (IFU) WERE 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, THE RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE IDENTIFIED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ¿AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM.¿. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    AN ENDOSCOPIC SUPPORT SPECIALIST PROVIDED A REPROCESSING IN-SERVICE AT THE USER FACILITY, WHICH INCLUDED ALL CLEANING, LEAK TESTING, HIGH LEVEL DISINFECTION, DELAYED REPROCESSING AND STORAGE USING INFORMATION CONTAINED IN THE OLYMPUS REPROCESSING MANUAL. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000418. THIS EVENT WAS SUBMITTED BY THE USER FACILITY UNDER THIS MDR NUMBER 1184621211-2024-0001. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE FOUR (4) POTENTIAL PATIENTS DIRECTLY IMPACTED BY ONE SUSPECTED MEDICAL DEVICE. THE PATIENTS UNDERWENT PROCEDURES INVOLVING THE SAME INDIVIDUAL SUSPECTED MEDICAL DEVICE BETWEEN (B)(6) 2024. THE PATIENT REFERENCED IN THIS REPORT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024 FOR CHOLECYSTITIS AND SEPTIC SHOCK. THE PATIENT'S BLOOD CULTURES WERE POSITIVE FOR PAN SENSITIVE E. COLI ON ADMISSION. THE PATIENT UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH SUSPECTED MEDICAL DEVICE TO REMOVE STONES ON (B)(6) 2024. THE PATIENT'S GALLBLADDER DRAIN WAS CULTURED ON (B)(6), 2024 AND WAS POSITIVE FOR CARBAPENEM RESISTANT E. COLI (CP-CRE). THE CP-CRE WAS NOT TREATED SINCE THE PATIENT WAS IMPROVING ON CURRENT REGIMEN. THE PATIENT WAS DISCHARGED ON HOME HEALTH ON (B)(6) 2024. ON (B)(6) 2024, ERCP PROCEDURE INVOLVING SUSPECTED MEDICAL DEVICE WAS IDENTIFIED AS POSSIBLE LINK BETWEEN MULTIPLE CP-CRE INFECTIONS. ON AUGUST 21, 2024, SUSPECTED MEDICAL DEVICE WAS EXAMINED BY BORESCOPE DURING FACILITY INVESTIGATION. BORESCOPE REVEALED A SMALL TEAR WITHIN THE INNER SHEATH OF THE DEVICE. IT IS UNKNOWN WHEN THE TEAR APPEARED ON THE SCOPE, WHAT CAUSED IT, AND WHETHER IT WAS PRESENT FOR ERCP PROCEDURES INVOLVING AFFECTED PATIENTS. THE CUSTOMER REITERATED THAT THE DEVICE HAD AN INNER SHEATH TEAR, WHICH THE CUSTOMER WAS NOT AWARE OF, AND THEY USED THE SCOPE ON SEVERAL PATIENTS. THE CUSTOMER FURTHER STATED THAT THE DEVICE MIGHT HAVE CAUSED A CROSS CONTAMINATION BETWEEN PATIENTS. REPORTEDLY, THE DEVICE HAS BEEN IN QUARANTINE IN A SECURE LOCATION. THE CUSTOMER CONFIRMED THAT THE DEVICE PASSED THE LEAK TEST PRIOR TO PROCEDURES BEING DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161767 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Other EXTRACTOR PRO RX 7-6F 15-18MM 200CM| HYDRATOME RX 4.4F 20MM W/ 260CM GW| RX ACCESSORY RAPID REFILL CONT LNJ SYSTEM| SPYSCOPE DS II DIGITAL ACCESS & DELIVERYCATH 4661| SYPGLASS RETRIEVAL BASKET 286CM X 15MM