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

Model Number SD-400U-10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/11/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 301634260
• Report Number: 2429304-2022-00080
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04953170408243
• UDI-Public: 04953170408243
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2022,10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other