BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODENOVIDEOSCOPE

    MDR report key: 20977138 · Received December 19, 2024

    Report

    Report Number
    9610595-2024-40654
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    August 12, 2024
    Report Date
    February 11, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    PMA / PMN Number
    K954451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE FINAL INVESTIGATION. UPDATED FIELDS: D8, H6. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    E1 USER FACILITY: (B)(6) HOSPITAL. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE ¿A COMPARATIVE STUDY OF TRANSPANCREATIC SPHINCTEROTOMY, DOUBLE GUIDEWIRE TECHNIQUE, AND PRECUT SPHINCTEROTOMY IN DIFFICULT NAIVE BILIARY CANNULATIONS IN A TERTIARY CARE CENTER IN WESTERN INDIA¿. INTRODUCTION: DIFFICULT BILIARY CANNULATION LEADS TO PROLONGED PAPILLARY MANIPULATION AND REPEATED ATTEMPTS AT CANNULATION ARE KNOWN TO INCREASE THE RISK OF POSTENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PANCREATITIS. THIS STUDY AIMS TO COMPARE THE EFFICACY AND COMPLICATIONS OF THREE RESCUE METHODS, TRANSPANCREATIC BILIARY SPHINCTEROTOMY (TP), DOUBLE GUIDEWIRE TECHNIQUE (DGW), AND PRECUT SPHINCTEROTOMY (PRECUT) IN DIFFICULT COMMON BILE DUCT (CBD) CANNULATIONS. METHODS: SEVENTY-SIX PATIENTS (>12 YEARS OF AGE) WITH A NATIVE PAPILLA UNDERGOING ERCP FOR BILIARY CANNULATION WERE RECRUITED. THOSE WHO HAD INADVERTENT PANCREATIC DUCT CANNULATIONS (>1) WERE INCLUDED. A PANCREATIC STENT WAS INSERTED IN ALL CASES. THEY UNDERWENT EITHER DGW (N = 25), PRECUT (N = 25), OR TP (N = 26) AS RESCUE METHODS AND WERE COMPARED IN TERMS OF THE SUCCESS OF CANNULATION AND POST-ERCP COMPLICATIONS. RESULTS: OF THE TOTAL 76 CASES, 82% WERE FOR BENIGN INDICATIONS, THE MOST COMMON BEING CHOLEDOCHOLITHIASIS (69.7%). JAUNDICE WAS NOTED IN 52% (N = 13/25), 60% (N = 15/25), AND 38.5% (N = 10/26) OF THE DGW, PRECUT, AND TP CASES, WHILE 40% (N = 10/25), 12% (N = 3/25), AND 30.8% (N = 8/26), RESPECTIVELY, WERE IN CHOLANGITIS AT PRESENTATION. THE MOST COMMON TYPE OF PAPILLA WAS TYPE 1 OVERALL AND EACH SUBGROUP. WHILE SUCCESSFUL CANNULATION WAS ACHIEVED IN 88.5% (N = 23/26) OF TP AND 84% (N = 21/25) OF THE DGW GROUP, ONLY 64% (N =16/25) OF THE PRECUT CASES WERE CANNULATED. THREE (N = 3/25) CASES HAD MILD BLEEDING AND TWO MILD PANCREATITIS, ONE SEVERE PANCREATITIS, AND ONE PERFORATION WERE RECORDED IN THE PRECUT GROUP. ONE PATIENT EACH HAD SEVERE AND MILD PANCREATITIS IN THE DGW GROUP, WHILE ONE HAD MILD PANCREATITIS AND TWO HAD MODERATE PANCREATITIS IN THE TP GROUP. ALL THE PATIENTS WERE MANAGED CONSERVATIVELY. CONCLUSION: THERE WAS NO SIGNIFICANT DIFFERENCE IN THE TECHNICAL SUCCESS RATE (P = 0.075) AS WELL AS COMPLICATIONS (P = 0.117) BETWEEN THE THREE SALVAGE METHODS FOR DIFFICULT NAIVE CBD CANNULATIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: MILD TO SEVERE PANCREATITIS (B)(4). PERFORATION (B)(4). MILD BLEEDING (B)(4). HOSPITALIZATION (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951017 DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-150

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization