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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Respiratory Problem (4464)
Date of Event	03/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifiers: (b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Olympus reviewed the following literature titled "feasibility and efficacy of gastric underwater endoscopic mucosal resection." this retrospective observational study was conducted at a tertiary medical center, focusing on patients who underwent uemr for treatment of gastric neoplasms between (b)(6) 2019 and (b)(6) 2023.A total of 81 patients were included (76 patients in uemr group and 5 patients in esd group).Type of adverse events/number of patients.Immediate bleeding - 30 (36.8%).Atelectasis - 6 (6.6%).In cases of immediate bleeding, hemostasis was achieved using either snare tip or electrosurgical hemostatic forceps.An endoscopic clip was also used in cases where hemostasis was not achieved by the usual methods.Atelectasis was identified by comparing post-procedure chest radiograms with those taken before the endoscopic resection, irrespective of the presence of clinical symptoms.Radiological indicators of atelectasis included both direct and indirect signs.Direct signs included the convergence of pulmonary vessels, clustered air bronchograms, and shifting of the interlobar fissures.Indirect signs were opacification of the lung tissue and upward movement of the diaphragm on the affected side.Routine follow-up endoscopies were planned for approximately 3 to 6 months after resection to monitor for any recurrence, with a thorough examination and biopsy of the resected area.Asymptomatic atelectasis occurred in approximately 6.6% of cases.Which led to the development of atelectasis in the left lower lung field in some patients.These instances were temporary and occurred without fever or respiratory symptoms.
Event or Problem Description
The following additional information was received from the author: an olympus device did not cause or contribute to the adverse event described in the article.Also, it was confirmed that an olympus device malfunction did not occur.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information received from the author (b5).The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.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: 19455304
• Report Number: 9614641-2024-01195
• Device Sequence Number: 12539431
• Product Code: FDI
• UDI-Device Identifier: 04953170408250
• UDI-Public: 04953170408250
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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
• 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: 05/07/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GIF-HQ290.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown