MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL SNARE SD-400

Model Number	SD-400U-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus medical systems corp.(omsc) reviewed a literature titled, "utility of prophylactic clipping after colorectal cold snare polypectomy in patients on oral antithrombotic agents." literature summary background and aims: there is no consensus on the effectiveness of prophylactic clipping after colonic cold snare polypectomy (csp).This study aimed to evaluate the utility of prophylactic clipping in preventing delayed bleeding (db) after colorectal csp in patients on antithrombotic agents.Methods: we retrospectively recruited consecutive patients on antithrombotic agents who underwent colorectal csp in (b)(6) hospital.The db rate was compared between patients with and without prophylactic clipping.Results: the study included 133 patients (422 polyps) requiring prophylactic clipping and 85 patients (282 polyps) not requiring prophylactic clipping.There were no significant differences in db and hematochezia rates between the groups.By weighted logistic regression analysis, the odds ratio of hematochezia was 0.557 (95% confidence interval, 0.225-1.378; p =.205) in patients without clipping compared to those with clipping.The rates of hematochezia and db were 4% (5 of 133) and 2% (2 of 133) in the clipping group and 5% (4 of 85) and 0% (0 of 85) in the non-clipping group (p z.741 and p z.522, respectively).None of the patients who had hematochezia fell into the condition of hospitalization, emergency department visit, transfusion, or radiologic/endoscopic intervention.In the present cohort, 2 patients experienced db after prophylactic clipping.Case 1 involved a 79-year-old male patient who underwent resection of a 2-mm low-grade adenoma in the cecum while on a direct-acting oral anticoagulant.Delayed bleeding was observed 3 days after csp.The exposed vessel was observed in the post-csp ulcer.Case 2 involved a 74-year-old male patient who underwent resection of a 4-mm low-grade adenoma in the cecum while on warfarin.Delayed bleeding was observed 1 day after csp.Active bleeding was observed in the post-csp ulcer.In both cases, bleeding was successfully stopped with additional clipping.Conclusions: prophylactic clipping may not be necessary to prevent db after colorectal csp in patients on antithrombotic agents.This report is for the 74-year-old patient with delayed bleeding 1 day after csp and underwent additional clipping.This event includes 4 reports.This report is 3 of 4.
Additional Manufacturer Narrative
E1 - initial reporter establishment name: (b)(6).Since the literature described a "snare master plus", olympus selected "sd-400u-10" as the representative product.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.

• Brand Name: SINGLE USE ELECTROSURGICAL SNARE SD-400
• Common Device Name: 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: 25445115
• Report Number: 9614641-2026-00601
• Device Sequence Number: 14912937
• Product Code: FDI
• UDI-Device Identifier: 04953170396694
• UDI-Public: 04953170396694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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-400U-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/09/2026
• 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: EZ CLIP BY OLYMPUS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male