BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 18649634 · Received February 6, 2024

    Report

    Report Number
    9610595-2024-02513
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    November 15, 2022
    Report Date
    February 29, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. DOI.ORG/10.5946/CE.2022.021 PROVIDED FOR ADDITIONAL INFORMATION. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENTS CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS RECEIVED THE FOLLOWING LITERATURE TITLED "PANCREATIC DUCT LAVAGE CYTOLOGY COMBINED WITH A CELL-BLOCK METHOD FOR PATIENTS WITH POSSIBLE PANCREATIC DUCTAL ADENOCARCINOMAS, INCLUDING PANCREATIC CARCINOMA IN SITU.". BACKGROUND/AIMS: THIS STUDY AIMED TO CLARIFY THE EFFICACY AND SAFETY OF PANCREATIC DUCT LAVAGE CYTOLOGY COMBINED WITH A CELL-BLOCK METHOD (PLC-CB) FOR POSSIBLE PANCREATIC DUCTAL ADENOCARCINOMAS (PDACS). METHODS: THIS STUDY INCLUDED 41 PATIENTS WITH SUSPECTED PDACS WHO UNDERWENT PLC-CB MAINLY BECAUSE THEY WERE UNFIT FOR UNDERGOING ENDOSCOPIC ULTRASONOGRAPHY-GUIDED FINE NEEDLE ASPIRATION. A 6-FR DOUBLE LUMEN CATHETER WAS MAINLY USED TO PERFORM PLC-CB. FINAL DIAGNOSES WERE OBTAINED FROM THE FINDINGS OF RESECTED SPECIMENS OR CLINICAL OUTCOMES DURING SURVEILLANCE AFTER PLC-CB. RESULTS: HISTOCYTOLOGICAL EVALUATIONS USING PLC-CB WERE PERFORMED IN 87.8% (36/41) OF THE PATIENTS. FOR 31 OF THE 36 PATIENTS, FINAL DIAGNOSES (INVASIVE PDAC, 12; PANCREATIC CARCINOMA IN SITU, 5; BENIGNANCY, 14) WERE MADE, AND THE REMAINING FIVE PATIENTS WERE EXCLUDED DUE TO LACK OF SURVEILLANCE PERIODS AFTER PLC-CB. FOR 31 PATIENTS, THE SENSITIVITY, SPECIFICITY, AND ACCURACY OF PLC-CB FOR DETECTING MALIGNANCY WERE 94.1%, 100%, AND 96.8%, RESPECTIVELY. IN ADDITION, THEY WERE 87.5%, 100%, AND 94.1%, RESPECTIVELY, IN 17 PATIENTS WITHOUT PANCREATIC MASSES DETECTABLE USING ENDOSCOPIC ULTRASONOGRAPHY. FOUR PATIENTS DEVELOPED POSTPROCEDURAL PANCREATITIS, WHICH IMPROVED WITH CONSERVATIVE THERAPY. CONCLUSIONS: PLC-CB HAS AN EXCELLENT ABILITY TO DETECT MALIGNANCIES IN PATIENTS WITH POSSIBLE PDACS, INCLUDING PANCREATIC CARCINOMA IN SITU. POST-ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PANCREATITIS (PEP) DEVELOPED IN FOUR PATIENTS (9.8%; MODERATE SEVERITY, 3; MILD SEVERITY, 1). OF THE FOUR PATIENTS WITH PEP, ONE PATIENT WITH MODERATE PEP DID NOT UNDERGO PANCREATIC STENT REPLACEMENT AND ADMINISTRATION OF NSAIDS, WHEREAS THE REMAINING THREE UNDERWENT BOTH PROPHYLACTIC TREATMENTS. THE PEP IN THESE PATIENTS IMPROVED WITH CONSERVATIVE TREATMENT. NO OTHER ADVERSE EVENTS ASSOCIATED WITH ERCP WERE OBSERVED IN ANY OF THE PATIENTS. RELATED PATIENT IDENTIFIERS: CASE (B)(4) (66, MALE): (B)(6) - EVIS LUCERA DUODENOVIDEOSCOPE (TJF-260V); (B)(6) - CANNULA (PR-104Q-1). CASE (B)(4) (61, FEMALE): (B)(6) - EVIS LUCERA DUODENOVIDEOSCOPE (TJF-260V) ; (B)(6) - CANNULA (PR-104Q-1) CASE 16. CASE (B)(4) (79, FEMALE): (B)(6) - EVIS LUCERA DUODENOVIDEOSCOPE (TJF-260V); (B)(6) - CANNULA (PR-104Q-1) . CASE (B)(4) (75, FEMALE): (B)(6) - EVIS LUCERA DUODENOVIDEOSCOPE (TJF-260V) ; (B)(6) - CANNULA (PR-104Q-1). THIS MEDWATCH IS FOR PATIENT IDENTIFIER (B)(6) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463325 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention CANNULA (PR-104Q-1)