BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 10790509 · Received November 5, 2020

    Report

    Report Number
    8010047-2020-08561
    Event Type
    Injury
    Date Received
    November 5, 2020
    Report Date
    November 5, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    PMA / PMN Number
    K950166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 OCTOBER 12, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "PERORAL CHOLANGIOSCOPY-GUIDED FORCEPS BIOPSY AND ENDOSCOPIC SCRAPER FOR THE DIAGNOSIS OF INDETERMINATE EXTRAHEPATIC BILIARY STRICTURE". THE PURPOSE WAS TO EVALUATE THE EFFICACY AND SAFETY OF TREFLE®-ASSISTED TISSUE ACQUISITION FOR DIAGNOSING EXTRAHEPATIC CHOLANGIOCARCINOMA (ECC) COMPARED WITH PERORAL CHOLANGIOSCOPY (POCS) GUIDED TISSUE SAMPLING. IN THE LITERATURE, IT WAS REPORTED THAT 1 SEVERE HEMORRHAGE RELATED TO ENDOSCOPIC SPHINCTEROTOMY (EST) DURING POCS WAS OBSERVED IN 34 PATIENTS WITH BILIARY DISEASE RETROSPECTIVELY WHO UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) TISSUE ACQUISITION WITH TREFLE® AND/OR POCS TO DIFFERENTIATE CHOLANGIOCARCINOMA FROM BENIGN BILIARY DISEASE BETWEEN APRIL 2014 AND MARCH 2018 AT TOTTORI UNIVERSITY HOSPITAL, JAPAN. THE CASE WAS RESOLVED WITH CONSERVATIVE TREATMENT. DURING THE ERCP THE SURGEON USED A SIDE-VIEWING DUODENOSCOPE (JF260V/TJF240V; OLYMPUS), AND A 0.035-INCH HYDROPHILIC GUIDEWIRE (NON-OLYMPUS) AND/OR A 0.025-INCH HYDROPHILIC GUIDEWIRE (G-260-2545A; OLYMPUS. MTA0025N48S; NON-OLYMPUS. M00556700; NON-OLYMPUS). ALSO, DURING THE POCS THE SURGEON USED MINI ENDOSCOPY (92176864-01A; NON-OLYMPUS) DIRECT VISUALIZATION SYSTEM AND A 1.0-MM DIAMETER CUP (M00546270; NON-OLYMPUS). THE AUTHOR WROTE, "EST WAS CARRIED OUT FOR DIFFICULT CASES, WHEREBY THE ENDOSCOPIC DEVICES ARE INSERTED INTO THE BILE DUCT USING A SPHINCTEROTOME (KD-V411M-0725; OLYMPUS OPTICAL CO., LTD.), IF IT WAS NOT PREVIOUSLY PERFORMED AND IT WAS NECESSARY." BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, THE AUTHOR WROTE, "SEVERE HEMORRHAGE RELATED TO EST OCCURRED IN ONE PATIENT." THEREFORE, OMSC WILL SUBMIT 1 MEDICAL DEVICE REPORT (MDR) OF KD-V411M-0725 FOR 1 SEVERE HEMORRHAGE RELATED TO EST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258276 SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-V411M-0725

    Patients

    Seq Age Sex Outcome Treatment
    1