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

Model Number SD-210L-10

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

Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 09/14/2022

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "underwater endoscopic submucosal dissection and hybrid endoscopic submucosal dissection as rescue therapy in difficult colorectal cases".This retrospective analysis demonstrates that underwater esd (u-esd) and hybrid esd (h-esd) are both effective and safe as rescue therapy in difficult colorectal esd.There were fifty-nine colorectal neoplasms were considered, 22 of which were removed by u-esd and 37 by h-esd.The en bloc resection rate in the u-esd group was 100%, while it was 59.5% in the h-esd group.Dissection speed was 17.7mm2/min in the u-esd group and 8.3mm2/min in the h-esd group.This study concludes that the u-esd and h-esd are both effective and safe techniques in difficult colorectal situations.U-esd is particularly effective and fast for large lesions when it is not possible to obtain comfortable knife position, while h-esd is more suitable for very fibrotic lesions.Type of adverse events/number of patients [underwater esd], bacteremia - 1 patient [hybrid esd], perforation - 4 patients, bleeding - 4 patients, bacteremia - 1 patient.This literature article requires 4 reports.The related patient identifiers are as follows: (b)(6); (kd-10q-1) (b)(6); (kd-650l: single use electrosurgical knife) (b)(6); (sd-210l-10: snare master) (b)(6); (fd-210u: hot biopsy) this medwatch report is for patient identifier (b)(6); there is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

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 Description

In the medical opinion of the author, the olympus device did not cause malfunction nor the adverse events reported.

Manufacturer Narrative

This supplemental report is being submitted to provided additional information from the author (see b5).

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 a correction to e4 and g2.Information added that was inadvertently not included on previous submissions.Olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Type of Device: DISPOSABLE 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: 16090129
• MDR Text Key: 306597632
• Report Number: 9614641-2023-00006
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04953170298462
• UDI-Public: 04953170298462
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD-210L-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
• Date Manufacturer Received: 01/16/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention