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

Model Number	SD-210U-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Bowel Perforation (2668)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in a clinical study patient, colonoscopy was performed at an outpatient clinic, and polyps were removed from 20 lesions from the cecum to the rectum.One lesion in the ascending colon and one lesion in the transverse colon were deemed eligible for this study, and the patient was enrolled in the study and underwent protocol treatment.There were no adverse events during surgery, and the patient was discharged the same day.Later, on the night after the surgical procedure, the patient visited the emergency room complaining of abdominal pain.After detailed examination, the patient was diagnosed with delayed perforation after polypectomy.Emergency surgery was performed on the same day, and a perforation was found in the cecum contralateral to the ileocecal region, and a partial appendectomy and lavage drainage were performed.The site of the perforation was the site where appendiceal adenoma had been removed with hot snare polypectomy and treated according to the protocol, and it has been determined that there is no problem with continuing the clinical study.The procedure was completed with the same device.No reports of further patient harm/injury.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 subject device was not returned, and the root cause of the suggested event could not be determined.The event can be detected/prevented by following the instructions for use which state: "always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures.Excessive output level and time may result in patient injury, such as punctures, hemorrhages or mucous membrane damage." "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 abnormalities are found in the patient." 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20242169
• Report Number: 9614641-2024-01843
• Device Sequence Number: 15476279
• Product Code: FDI
• UDI-Device Identifier: 04953170298424
• UDI-Public: 04953170298424
• 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,User Facility,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-210U-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: 09/02/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 09/17/2024
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian