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

Model Number	SD-400U-15
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed, a supplemental report will be submitted with the device evaluation results.
Event or Problem Description
It was reported that when performing a cold polypectomy on a polyp with a lesion size of 5 mm ("cold cut" -therapeutic procedure) in the large intestine, the polyp could not be detached/torn when it was strangled with a single use electrosurgical snare.Due to the inability to perform polypectomy, the procedure was changed to "emr procedure" and the polyp was mechanically excised which could then be removed from the tissue ("the treatment was performed by locally injecting it into the treatment area without using high frequency") the procedure was extended; however, the delay is unknown.The procedure was completed by replacing the device.No additional medication was given to the patient no reports of health hazards to the patient.Futher procedural details and outcome of patient were requested but not available at the time of the report.
Event or Problem Description
Additional information received.It was reported that the patient did not receive additional anesthesia.No additional adverse effects or complications to the patient, due to the device malfunction.No particular change to the patient's correct condition.And the patient's outcome was favorable.Additionally, excision was performed in the cold.Endoscopic mucosal resection (emr) using high frequency was performed, because the excision could not be performed.The reason the user changed to emr occurred, due to not being able to perform cold cuts.The user was grasping the muscle layer rather than the superficial membrane of the tissue they were trying to remove (the part that could not be removed), so the user inflated the tissue with local injection.This is to allow the surgeon to remove the tumor by gripping it firmly with a snare.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out (d4-lot number) and to provide updates to fields (b5, h3 and h4).The device was evaluated by olympus.And no reportable malfunctions were found, that could have led to the reported event.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported event could not be identified with the information received.The event can be detected/prevented, by following the instructions for use, which state: "do not use excessive force when snaring tissue.This could cause patient injury, such as hemorrhages or mucous membrane damage"."do not snare tissue with excessive force.This could break the snare loop".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: 18908881
• Report Number: 9614641-2024-00669
• Device Sequence Number: 7683097
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SD-400U-15
• Device Lot Number: 2XV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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