BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODENOVIDEOSCOPE

    MDR report key: 11654005 · Received April 12, 2021

    Report

    Report Number
    8010047-2021-04858
    Event Type
    Injury
    Date Received
    April 12, 2021
    Report Date
    April 13, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE WAS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 1

    ON MARCH 29, OMSC RECEIVED THE LITERATURE "A COMPARISON BETWEEN NON-SEDATION AND GENERAL ENDOTRACHEAL ANESTHESIA FOR RETROGRADE ENDOSCOPIC COMMON BILE DUCT STONE REMOVAL: A TERTIARY CENTER EXPERIENCE". THE PURPOSE OF THE LITERATURE WAS TO COMPARE THE SAFETY AND RATE OF SUCCESS AND COMPLICATIONS DURING COMMON BILE DUCT (CBD) STONE EXTRACTION USING ENDOSCOPIC RETROGRADE COLANGIOPANCREATOGRAPHY (ERCP) PERFORMED WITH NO-SEDATION (NS) OR UNDER GENERAL ENDOTRACHEAL ANESTHESIA (GET). THE PROCEDURE WAS PERFORMED USING A SCOPE (OLYMPUS; JF-260V AND TJF-240) AND A CHOLANGIOGRAPHY CATHETER (OLYMPUS: PR-113Q). NON-OLYMPUS GUIDEWIRE WAS USED. THE SUBJECTS WERE 630 PATIENTS WHO UNDERWENT ERCP FOR BILIARY STONE EXTRACTION BETWEEN JANUARY 2010 AND SEPTEMBER 2013 AND CLASSIFIED TO THE NS AND GET GROUPS. IN THE LITERATURE, IT WAS REPORTED 3 PERFORATIONS. IT WAS NOT FOUND WHETHER 3 PERFORATIONS OCCURRED DURING OR AFTER PROCEDURE, WHAT SEVERE 3 PERFORATIONS WERE, AND WHAT MODEL OF DUODENOSCOPE WAS USED WHEN EACH PERFORATION OCCURRED. THE LITERATURE WROTE ABOUT OTHER COMPLICATIONS (48 POST-ERCP PANCREATITIS, 6 BLEEDINGS, 16 PNEUMONIA, AND 7 MORTALITY) AS BELOW. ¿IN OUR STUDY, WE CALCULATED OPERATIVE TIME FROM THE TIME OF THE START OF CANNULATION TO CBD STONE CLEARANCE, WITH AN OPERATIVE TIME 30 MIN BEING AN INDEPENDENT RISK FACTOR FOR PEP. EVALUATING THE ASSOCIATION BETWEEN BOTH IATROGENIC AND NON-IATROGENIC FACTORS FOR PEP (TABLE 5), THE BILIARY PANCREATITIS, AND CONTRACT INJECTION INTO THE PANCREATIC DUCT WERE ALSO INDEPENDENT PREDICTIVE FACTORS FOR PEP.¿ BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THESE PERFORATIONS COULD NOT BE DETERMINED. THIS IS THE REPORT REGARDING THREE PERFORATIONS FOR A DUODENOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549702 DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other