BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 13544217 · Received February 16, 2022

    Report

    Report Number
    8010047-2022-03055
    Event Type
    Injury
    Date Received
    February 16, 2022
    Report Date
    March 29, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE AUTHOR'S RESPONSE WITH ADDITIONAL INFORMATION AND THE LEGAL MANUFACTURER'S INVESTIGATION. NEW INFORMATION ADDED. THE DEVICE HISTORY RECORDS (DHR) FOR THIS DEVICE COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. OLYMPUS SHIPS DEVICES MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MEET FINAL PRODUCT RELEASE CRITERIA. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER WAS UNABLE TO DETERMINE THE PROBABLE CAUSE OF THE ADVERSE EVENTS, THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDE BY THE AUTHOR: THE AUTHOR PROVIDED HIS MEDICAL OPINION REGARDING THE RELATIONSHIP BETWEEN THE PATIENTS' WITH PANCREATITIS AND THE OLYMPUS DEVICES. DR. (B)(6) STATED THE PANCREATITIS COULD BE CAUSED BY THE PROCEDURE ITSELF AND NOT THE OLYMPUS DEVICE. HE STATED TREATMENT WAS NOT NEEDED, THE PATIENTS WERE MONITORED SINCE THE PANCREATITIS WAS MILD.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE, "DIAGNOSTIC APPROACH USING ERCP-GUIDED TRANSPAPILLARY FORCEPS BIOPSY OR EUS-GUIDED FINE-NEEDLE ASPIRATION BIOPSY ACCORDING TO THE NATURE OF STRICTURE SEGMENT FOR PATIENTS WITH SUSPECTED MALIGNANT BILIARY STRICTURE" BY YUN NAH LEE, JONG HO MOON, HYUN JONG CHOI ET AL. THIS STUDY AIMED TO EVALUATE THE USEFULNESS OF A DIAGNOSTIC APPROACH USING ERCP-GUIDED TRANSPAPILLARY FORCEPS BIOPSY (TPB) OR EUS-FNAB ACCORDING TO THE CHARACTERISTICS OF SUSPECTED MBS. CONSECUTIVE PATIENTS DIAGNOSED WITH SUSPECTED MBS WITH OBSTRUCTIVE JAUNDICE AND/OR CHOLANGITIS WERE ENROLLED PROSPECTIVELY. ERCP WITH INTRADUCTAL ULTRASONOGRAPHY (IDUS) AND TPB WERE PERFORMED AS INITIAL DIAGNOSTIC PROCEDURES. BASED ON THE RESULTS OF IMAGING STUDIES AND IDUS, ALL MBS WERE CLASSIFIED AS EXTRINSIC OR INTRINSIC TYPE. IF THE MALIGNANCY WAS NOT CONFIRMED BY TPB, EUS-FNAB FOR EXTRINSIC TYPE OR SECOND TPB FOR INTRINSIC TYPE WAS PERFORMED. AMONG A TOTAL OF 178 PATIENTS, INTRINSIC AND EXTRINSIC TYPES WERE DETECTED IN 88 AND 90 PATIENTS, RESPECTIVELY. THE DIAGNOSTIC ACCURACY OF FIRST TPB WAS SIGNIFICANTLY HIGHER IN THE INTRINSIC THAN IN THE EXTRINSIC TYPE (81.8% VS. 67.8, P = 0.023). IN 33 PATIENTS WITH EXTRINSIC TYPE AND NEGATIVE FOR MALIGNANCY ON FIRST TPB, THE DIAGNOSTIC ACCURACY OF EUS-FNAB WAS 90.9%. IN 19 PATIENTS WITH INTRINSIC TYPE AND NEGATIVE FOR MALIGNANCY ON FIRST TPB, THE DIAGNOSTIC ACCURACY OF SECOND TPB WAS 84.2%. THE DIAGNOSTIC ACCURACIES OF THE COMBINATION OF INITIAL TPB WITH EUS-FNAB AND SECOND TPB WERE 96.7% AND 96.6%, RESPECTIVELY. A DIAGNOSTIC APPROACH USING EUS-FNAB OR TPB ACCORDING TO THE ORIGIN OF MBS IS CONSIDERED EFFECTIVE TO IMPROVE THE DIAGNOSTIC ACCURACY OF MBS WITH NEGATIVE FOR MALIGNANCY ON FIRST TPB THE AUTHORS USED MULTIPLE OLYMPUS DEVICES AND DID NOT SPECIFY WHICH OLYMPUS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE MILD PANCREATITIS. THIS ARTICLE INCLUDES 5 REPORTS: (B)(6): FB-39Q, (B)(6): JF-260V, (B)(6): TJF-260V, (B)(6): GF-UCT24, (B)(6): UM-G20-29R, THIS IS REPORT 2 OF 5 FOR (B)(6): JF-260V.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011675 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. JF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other FB-39Q, TJF-260V, UM-G20-29R, GF-UCT240