BEUDAMED
    FDA Adverse Event Summary report: N

    OLYMPUS TJF-Q190V, SERIAL #2021538

    MDR report key: 16215267 · Received January 19, 2023

    Report

    Report Number
    MW5114400
    Date Received
    January 19, 2023
    Date of Event
    January 11, 2023
    Report Date
    January 17, 2023
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A SMALL PROTECTIVE PLASTIC END-CAP CAME OFF DISTAL END OF SCOPE, PRESUMABLY AT END OF CASE AS MD REMOVED SCOPE. THE END-CAP WAS SECURED WITH MANUAL PRESSURE BEFORE CASE STARTS AND ACCORDING TO VALIDATED MANUFACTURER'S INSTRUCTIONS FOR USE. THIS CAP IS TYPICALLY PLACED TO STREAMLINE SCOPE & LIKELY PROTECT MUCOSA FROM INTRICATE, BARE METAL PARTS OF THE DISTAL END OF ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY SCOPE. IT IS LIKELY THE BITE BLOCK OR TEETH AIDED IN DISLODGING END-CAP AS SCOPE WAS REMOVED FROM PATIENT AND UNKNOWINGLY REMAINED SOMEWHERE WITHIN THE OROPHARYNX. PROVIDER USED A DIFFERENT SCOPE (ESOPHAGOGASTRODUODENOSCOPY) IN AN ATTEMPT TO VISUALIZE IF END-CAP WAS RETAINED IN ESOPHAGUS OR STOMACH, WHICH IT WAS NOT. MD RECOMMENDED NO FOLLOW UP AS CAP WOULD EVENTUALLY PASS WITH STOOL. AS PT WAS BECOMING MORE AWAKE AND STILL IN THE OR, STAFF NOTED THAT PT COUGHED UP SOMETHING THAT WAS IDENTIFIED AS THE END-CAP IN QUESTION. PT EVALUATED AND MONITORED THROUGHOUT CARE CONTINUUM AND NO ULTIMATE HARM NOTED TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347220 OLYMPUS TJF-Q190V, SERIAL #2021538 DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q190V

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female