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

Model Number	SD-400U-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event has been reported by the importer on mdr# 2429304 - 2022 - 00080.The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported in the literature titled ¿cold versus hot snare resection with or without submucosal injection of 6- to 15-mm colorectal polyps: a randomized controlled trial,¿ one patient experienced a serious adverse event after a hot snare rection procedure.Background and aims: cold snare resection of colorectal lesions has been found to be safe and effective for an expanding set of colorectal lesions.In this study, we sought to understand the efficacy of simple cold snare resection and cold emr versus hot snare resection and hot emr for colorectal lesions 6 to 15 mm in size.Methods: at 3 u.S.Centers, 235 patients with 286 colorectal lesions 6 to 15 mm in size were randomized to cold snaring, cold emr, hot snaring, or hot emr for nonpedunculated colorectal lesions 6 to 15 mm in size.The primary outcome was complete resection determined by 4 biopsy samples from the defect margin and 1 biopsy sample from the center of the resection defect.Results: the overall incomplete resection rate was 2.4% (95% confidence interval [ci],.8%-7.5%).All 7 incompletely removed polyps were 10 to 15 mm in size and removed by hot emr (n z 4, 6.2%), hot snare (n z 2, 2.2%), or cold emr (n z 1, 1.8%).Cold snaring had no incomplete resections, required less procedural time than the other methods, and was not associated with serious adverse events.Conclusions: cold snaring is a dominant resection technique for nonpedunculated colorectal lesions 6 to 15 mm in size.In the hot snare group one patient experienced a serious adverse event.The patient had a 14-mm cecal polyp removed by hot snare.The patient required hospitalization for 3 days, transfusion of 4 units of packed red blood cells, and repeat colonoscopy with clipping.At the 30-day follow-up the patient reported full recovery.
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.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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15589623
• Report Number: 9614641-2022-00459
• Device Sequence Number: 14155691
• Product Code: FDI
• UDI-Device Identifier: 04953170408243
• UDI-Public: 04953170408243
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Study,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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-10
• Device Lot Number: UNKNOWN(LITERATURE)
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other; Hospitalization; Required Intervention
• Patient Sex: Unknown