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

Model Number	SD-400U-10
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
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.

• 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
• MDR Report Key: 15589520
• Report Number: 2429304-2022-00080
• Device Sequence Number: 17936876
• Product Code: FDI
• UDI-Device Identifier: 04953170408243
• UDI-Public: 04953170408243
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2022
• Report Date (Section F): 09/13/2022

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?: Yes
• Distributor Facility Aware Date: 09/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown