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

Model Number	SD-400U-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a patient developed bloody stools after a low-power pure-cut hot snare polypectomy (lppc hsp).The device was used with no intraoperative bleeding and no clip closure.The patient had angina pectoris and was taking aspirin orally, which was discontinued 3 days before treatment and scheduled to be resumed the next day.Bloody stool was observed from the evening of the treatment day, and although the patient was instructed to postpone the resumption of aspirin, the bloody stool continued until post-op day 3 (pod3).On pod3, after pretreatment, a colonoscopy was performed, and exposed blood vessels equivalent to forrest classification iia were found at the ulcer base after lppc hsp.It was determined that the post-bleeding was due to lppc hsp, and clip closure was performed.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's (lm) investigation.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.The subject device was not returned to olympus for evaluation.Therefore, the condition of the device was not confirmed.Based on the results of the investigation, the root cause of the reported event could not be determined.The event can be detected/prevented, by following the instructions for use (ifu) which states: when applying the current, do not use an excessive amount of conduction.Doing so, could cause patient injury, such as perforations and/or bleeding.When necessary, provide treatments to prevent perforations or bleeding from occurring, after the procedure.Ensure that postoperative follow-ups are performed and confirm, that no irregularities are found in the patient.This supplemental report includes a correction to g2, to provide information that was inadvertently not included in the initial medwatch.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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20055422
• Report Number: 9614641-2024-01706
• Device Sequence Number: 7977953
• Product Code: FDI
• UDI-Device Identifier: 04953170408250
• UDI-Public: 04953170408250
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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-15
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/20/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown