MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL SNARE SD-400

Model Number SD-400U-15

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following literature: "impact of submucosal saline solution injection for cold snare polypectomy of small colorectal polyps: a randomized controlled study."     this study investigated whether submucosal injection of saline solution helps to achieve deeper resection in cold snare polypectomy (csp).Two hundred fourteen patients were randomly assigned to the csp-si (n = 107) or c-csp (n = 107) group.The rate of complete mm resection was 43.9% in the csp-si group and 53.3% in the c-csp group, a statistically insignificant difference.The rates of negative lateral margin and vertical margin (42.3% and 56.7%, respectively) in the csp-si group were significantly lower than those (58% and 76%) in the c-csp group (p=.03 and p=.006, respectively).There was no polypectomy-related major bleeding or perforation.Saline solution injection into the submucosa did not improve the resection depth of csp of small colorectal polyps, and the method resulted in lower rates of negative lateral and vertical margins of resected lesions.    major delayed bleeding was defined as hematochezia requiring emergent endoscopic hemostasis within 2 weeks after the procedure.Emergent endoscopy was performed for hematochezia that recurred at least twice, hematochezia with unstable vital signs (blood pressure 90 beats/min), or hematochezia with a more than 2-g/dl decrease of hemoglobin.Minor bleeding spontaneously ceased without intervention.    type of adverse events/number of patients: c-csp, major delayed bleeding - (1), minor delayed bleeding - (3), csp with injection, minor delayed bleeding - (4).This article includes 3 reports: patient identifier (b)(6)- pcf-q260azi.Patient identifier (b)(6)- pcf-h290zi.Patient identifier (b)(6)- sd-400u-15.This is report 3 of 3 for patient identifier (b)(6)- sd-400u-15.We selected "sd-400u-15" as a representative product for the snaremaster.

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 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.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information in b5 and h6.

Event Description

Three attempts were performed to obtain additional information, but no response was received from the author.

• Brand Name: SINGLE USE ELECTROSURGICAL SNARE SD-400
• Type of Device: ELECTROSURGICAL SNARE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14274183
• MDR Text Key: 293695243
• Report Number: 8010047-2022-07456
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04953170408250
• UDI-Public: 04953170408250
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD-400U-15
• 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
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0992-2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN SERIAL: (B)(6)
• Patient Outcome(s): Other; Required Intervention