BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 16390477 · Received February 16, 2023

    Report

    Report Number
    9610595-2023-02689
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Report Date
    May 11, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170405563
    PMA / PMN Number
    K220587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMUNICATION/RESPONSE FOLLOW UP WITH THE FACILITY'S NURSE GI LAB MANAGER: AS REPORTED BY THE GI MANAGER, "THE SPONGE WAS FOUND STUCK IN THE SCOPE CHANNEL AND PASSED THRU THE CLEANING PROCESS. GI MANAGER STATED THAT THE SPONGE WAS IN THE PATIENT¿S MOUTH WHEN IT WAS DISCOVERED AND WAS NOT IN THE PATIENT¿S GI TRACT. THE SCOPE WAS SENT FOR INVESTIGATION UNTIL IT¿S CLEARED BY OLYMPUS". THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED . DEVICE EVALUATION, INSPECTION OF THE FORCEPS PASSAGE WAS PERFORMED. INSPECTION FOUND TEAR MARKS ON WALLS OF CHANNEL. IN ADDITION, IMAGE CHECK FOUND ONE (1) WHITE DOT ON THE IMAGE. LOW ANGULATION WAS OBSERVED. CRACK FOUND ON A-RUBBER GLUE (BENDING SECTION) . INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. DURING THE EVALUATION THE CUSTOMERS COMPLAINT WAS UNABLE TO BE REPRODUCED. 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 ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. HOWEVER, THE CAUSE OF THE EVENT IS LIKELY DUE TO INSUFFICIENT OR INADEQUATE REPROCESSING. THE EVENT CAN BE DETECTED AND PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: OPERATION MANUAL 3.3 INSPECTION OF THE ENDOSCOPE. REPROCESSING MANUAL 5.5 MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED AN ISSUE OF " SOMETHING WAS STUCK IN THE WORKING CHANNEL". ACCORDING TO THE REPORT, CUSTOMER WAS ABLE TO REMOVED IT, HOWEVER, WOULD LIKE THE DEVICE INSPECTED/CHECKED. IN A FOLLOW UP COMMUNICATION , CUSTOMER STATED "A PIECE OF SPONGE THAT WAS USED TO CLEAN THE SCOPE WAS STUCK IN THE WORKING CHANNEL". THE DEFECT WAS OBSERVED DURING THE PROCEDURE (UNSPECIFIED). PER THE CUSTOMER, THE DOCTOR WAS INSERTING A SPHINCTEROTOME HOWEVER, IT WOULD NOT GO THROUGH. ANOTHER SCOPE WAS OBTAINED AND WHEN THE NURSE TRIED TO INSERT A BIOPSY FORCEPS , IT WAS FOUND THAT A SPONGE WAS STUCK. CUSTOMER STATED , THE SPONGE WAS DISPOSED RIGHT AFTER THE PROCEDURE. CUSTOMER STATED "THE SCOPE WAS INSERTED TO THE PATIENT¿S MOUTH AND THAT¿S ABOUT IT". SINCE THE SPHINCTEROTOME WOULD NOT GO THROUGH, THE DOCTOR IMMEDIATELY PULLED OUT AND REQUESTED FOR ANOTHER SCOPE". NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED . THIS REPORT IS BEING SUBMITTED DUE TO PIECE OF SPONGE FOUND STUCK IN THE WORKING CHANNEL OF THE SCOPE (PROBLEMS RELATED TO REPROCESSING, INSUFFICIENT REPROCESSING AND FORCEPS INSERTION ISSUE , CANNOT BE INSERTED , CHANNEL IS CLOGGED WITH FOREIGN SUBSTANCE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359738 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SPHINCTEROTOMEBIOPSY FORCEP