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

Model Number	SD-7P-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pancreatitis (4481)
Date of Event	08/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described "snare" olympus selected ¿sd-7p-1¿ as a representative product.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Olympus reviewed the following literature titled "efficacy and safety of cap-assisted endoscopic mucosal resection for superficial duodenal epithelial neoplasia <= 10 mm." this prospective study assessed the efficacy and safety of cap-assisted endoscopic mucosal resection (emrc) for the treatment of superficial duodenal epithelial neoplasia (sdet) = 10mm.A total of 248 patients were included.The r0 resection rate was 97.4% (222/228 cases), and the en bloc resection rate was 99.6% (227/228 cases).The post-emrc mucosal defect was entirely closed by otsc in 90.4% of patients (206/228 cases).Surveillance endoscopy to check for the presence of local recurrence showed no local recurrence after emrc (mean follow-up period; 30.1 months).Type of adverse events/number of patients delayed bleeding - 6 patients subsequent clipping or coagulation acute pancreatitis ¿ managed without surgical intervention this literature article requires 3 reports.The related patient identifiers are as follows: (b)(6): sd-7p-1 (b)(6) gif-q260j (b)(6) mh-592.There is no report of any olympus device malfunction in any procedure described in this study.
Event or Problem Description
The following additional information was received from the author: an olympus device did not cause or contribute to the adverse events described in the article.Also, no olympus device malfunction occurred during any of the events.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 event 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.This supplemental report includes additional information received from the author.Olympus will continue to monitor field performance for this device.

• Brand Name: ELECTROSURGICAL SNARE
• 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: 18369383
• Report Number: 9614641-2023-01962
• Device Sequence Number: 18037325
• Product Code: FAS
• UDI-Device Identifier: 04953170035951
• UDI-Public: 04953170035951
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024

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-7P-1
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown