BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 22331480 · Received June 25, 2025

    Report

    Report Number
    9610595-2025-12345
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    November 3, 2024
    Report Date
    July 17, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE AUTHOR AND THE RESULTS OF THE APPROVED FINAL INVESTIGATION. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION; THEREFORE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MOST PROBABLE CAUSE WAS NOT ESTABLISHED; THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6). E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). SINCE THE LITERATURE STATED, "GASTROINTESTINAL SCOPE WITH A WATER JET", OLYMPUS SELECTED ¿GIF-H290T¿ AS A REPRESENTATIVE PRODUCT. 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

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR THAT NO OLYMPUS DEVICES WERE REPORTED TO HAVE MALFUNCTIONED DURING ANY OF THE PROCEDURES DESCRIBED IN THE LITERATURE. THE AUTHOR FURTHER CONFIRMED THAT NO OLYMPUS DEVICE WAS IDENTIFIED AS THE CAUSE OR CONTRIBUTOR TO ANY OF THE PATIENT ADVERSE EVENTS DESCRIBED.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FEASIBILITY OF ENDOSCOPIC SUBMUCOSAL DISSECTION INCLUDING PAPILLA". BACKGROUND AND AIMS: ENDOSCOPIC PAPILLECTOMY (EP) IS A LOW-INVASIVE TREATMENT FOR DUODENAL TUMORS INCLUDING PAPILLA. THE LIMIT OF LESION SIZE AND LOCAL RECURRENCE HAVE BEEN ISSUES IN EP. WE DEVELOPED ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR THE TUMORS INCLUDING PAPILLA (ESDIP: ESD INCLUDING PAPILLA) TO OVERCOME THE PROBLEMS. THE AIM OF THIS STUDY WAS TO EVALUATE THE FEASIBILITY OF ESDIP. METHODS: WE INCLUDED THE PATIENTS WHO UNDERWENT ESDIP FROM AUGUST 2010 TO JANUARY 2024 IN THIS STUDY. WE EVALUATED THE RETROSPECTIVE CHARACTERISTICS OF PATIENTS AND LESIONS, CLINICAL RESULTS OF ESDIP AND OF ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AS PREVENTION FOR DELAYED ADVERSE EVENTS, AND PATHOLOGICAL FINDINGS. ALSO CALCULATED THE CUMULATIVE RECURRENCE RATE AND OVERALL SURVIVAL RATE AT 12 MONTHS AFTER ESDIP. RESULTS: FIFTY-FOUR PATIENTS WERE INCLUDED IN THIS STUDY. THE MEAN LESION SIZE WAS 39 MM. THE THIRD-QUARTER CASES REVEALED A LESS THAN HALF-CIRCUMFERENTIAL LESION, AND THE ONE CASE WITH A FULL-CIRCUMFERENTIAL LESION. RESECTION WAS ACCOMPLISHED IN 96% (N = 52), AND ALSO THE EN-BLOC RESECTION RATE WAS 96%. OF THE CASES IN ACCOMPLISHED RESECTION, 98% OF PATIENTS WERE INTUBATED WITH A PANCREATICOBILIARY DRAINAGE TUBE BY ERCP. INTRAPROCEDURAL PERFORATION OCCURRED IN EIGHT CASES. DELAYED BLEEDING OCCURRED IN 10 CASES. DELAYED PERFORATION WAS SEEN ONLY IN ONE CASE. THE INCIDENCE OF POST-ERCP PANCREATITIS WAS 25%. CUMULATIVE LOCAL RECURRENCE RATE AND THE OVERALL SURVIVAL RATE WERE 15% AND 96%, RESPECTIVELY. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: INTRAPROCEDURAL PERFORATION (8 PATIENTS). POSTPROCEDURAL BLEEDING (10 PATIENTS). POSTPROCEDURAL (DELAYED) PERFORATION (1 PATIENT). POST ENDOSCOPIC SUBMUCOSAL DISSECTION FOR THE DUODENAL TUMORS INCLUDING PAPILLA (ESDIP). PANCREATITIS (25% OF 54 PATIENTS). POST-ERCP PANCREATITIS (PEP) (25% OF 54 PATIENTS). MOST CASES OF ADVERSE EVENTS, EXCEPT ONE CASE OF DELAYED PERFORATION, WERE CONTROLLED ENDOSCOPICALLY. ALL CASES OF PANCREATITIS WERE CONSERVATIVELY CONTROLLED BY MASSIVE HYDRATION, REPOSITIONING THE PANCREATIC TUBE, AND/OR FLUSHING THE DEBRIS IN THE TUBE. CONCLUSION: ESDIP MAY BE FEASIBLE FOR DUODENAL TUMORS INCLUDING PAPILLA, AND IS A POTENTIAL ALTERNATIVE OPTION TO AVOID PANCREATICODUODENECTOMY. KEY WORDS: DUODENAL TUMOR, DUODENAL TUMORS INCLUDING PAPILLA, ENDOSCOPIC SUBMUCOSAL DISSECTION, ENDOSCOPIC SUBMUCOSAL DISSECTION INCLUDING PAPILLA, PAPILLARY TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142755 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H290T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GIF-Q260J GASTROINTESTINAL VIDEOSCOPE.| KD-655Q SINGLE USE ELECTROSURGICAL KNIFE.