MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE ELECTROSURGICAL SNARE

Model Number	SD-210U-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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).
Additional Manufacturer Narrative
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.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Common Device Name: DISPOSABLE ELECTROSURGICAL SNARE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 23302590
• Report Number: 9614641-2025-01709
• Device Sequence Number: 15940855
• Product Code: FDI
• UDI-Device Identifier: 04953170037009
• UDI-Public: 04953170037009
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K902735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Literature,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SD-210U-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TJF-Q290V EVIS LUCERA ELITE DUODENOVIDEOSCOPE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female