BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE ELECTROSURGICAL SNARE

    MDR report key: 23302590 · Received October 15, 2025

    Report

    Report Number
    9614641-2025-01709
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    May 14, 2025
    Report Date
    October 15, 2025
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FDI
    UDI-DI
    04953170037009
    PMA / PMN Number
    K902735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTS OF THE FOLLOWING PATIENT IDENTIFIERS ARE LINKED: (B)(6). E1 - INITIAL REPORTER ESTABLISHMENT NAME: (B)(6) MEDICAL CENTER. THE DEVICE WAS NOT RETURNED FOR EVALUATION; 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿SUCCESSFUL ENDOSCOPIC RESECTION BY USING GEL IMMERSION AND THE TECHNIQUE OF ENDOSCOPIC PAPILLECTOMY FOR A TUMOR ADJACENT TO THE PAPILLA OF VATER¿. LITERATURE SUMMARY. INTRODUCTION. SUPERFICIAL NONAMPULLARY DUODENAL EPITHELIAL TUMORS ARE RARE, AND THE ESTABLISHMENT OF OPTIMIZED STRATEGIES FOR THEIR TREATMENT IS AN AREA OF ACTIVE INVESTIGATION. ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR SUPERFICIAL NONAMPULLARY DUODENAL EPITHELIAL TUMORS POSES THE RISK OF MAJOR ADVERSE EVENTS (AES), INCLUDING A HIGH RATE OF BLEEDING, INTRAOPERATIVE PERFORATION, AND DELAYED PERFORATION. LESIONS LOCATED IN THE DUODENAL FLEXURE ARE ASSOCIATED WITH POOR ENDOSCOPE MANEUVERABILITY. MOREOVER, ENDOSCOPIC RESECTION IS PARTICULARLY CHALLENGING FOR LESIONS ON THE DESCENDING DUODENUM¿S MEDIAL WALL, ESPECIALLY THOSE ADJACENT TO THE PAPILLA OF VATER (POV). IF ENDOSCOPIC RESECTION IS NOT POSSIBLE, A PANCREATICODUODENECTOMY, WHICH IS A HIGHLY INVASIVE SURGERY, CAN BE PERFORMED. GEL IMMERSION ENDOSCOPY IS USED TO CONTROL GASTROINTESTINAL BLEEDING BY FLUSHING OUT BLOOD AND CLOTS TO SECURE A GOOD VISUAL FIELD. SINCE THERE IS NO CARBON DIOXIDE (CO2) INSUFFLATION DURING DUODENAL GEL IMMERSION ENDOSCOPY, ENDOSCOPIC MANEUVERING REMAINS STABLE WITH LOWER INTRALUMINAL PRESSURE, THUS PREVENTING REDUNDANT LOOPS IN THE STOMACH. HEREIN, WE REPORT A CASE IN WHICH VARIOUS ENDOSCOPIC TECHNIQUES, INCLUDING GEL IMMERSION ENDOSCOPY, WERE USED TO OVERCOME THE DIFFICULTY OF ENDOSCOPIC RESECTION OF A TUMOR THAT WAS ADJACENT TO THE POV. THIS GEL IMMERSION ENDOSCOPY PROCEDURE WAS APPROVED BY THE INSTITUTIONAL REVIEW BOARD OF SAITAMA MEDICAL UNIVERSITY INTERNATIONAL MEDICAL CENTER. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. PERFORATION (1 PATIENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338443 DISPOSABLE ELECTROSURGICAL SNARE DISPOSABLE ELECTROSURGICAL SNARE FDI AOMORI OLYMPUS CO., LTD. SD-210U-25 NI 04953170037009

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention TJF-Q290V EVIS LUCERA ELITE DUODENOVIDEOSCOPE.