MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE INJECTOR NM600/610; INJECTOR AND SHEATHSET

Model Number NM-610U-0423

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

Patient Problems Hemorrhage/Bleeding (1888); Bowel Perforation (2668)

Event Date 06/13/2022

Event Type  Injury  

Manufacturer Narrative

Since the literature described model number "nm600/610", olympus selected "nm-610u-0423" as a representative device.This event involves six related patient identifiers: (b)(6).This medwatch is for patient identifier (b)(6).The literature article is attached and doi: 10.1002/aid2.13344 is provided for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

Olympus reviewed the literature titled "risk factors for perforation during colorectal endoscopic submucosal dissection." endoscopic submucosal dissection (esd) achieves higher en bloc resection rates than endoscopic mucosal resection in early colorectal neoplasms.However, perforation occurs more frequently during esd.We aimed to identify the risk factors for perforation during colorectal esd.A total of 161 patients treated with colorectal esd at a tertiary center between january 2014 and december 2019 were enrolled in this retrospective study.Perforation was defined as a deep defect of the muscularis propria, with or without direct contact with connective tissue outside the colon.Clinical risk factors for perforation during esd, including age, sex, tumor morphology, tumor size, tumor location, procedure time, en bloc resection rate, histology, and submucosal fibrosis, were analyzed.The mean size of the esd specimens was 38.2 ± 24.6 mm.The overall en bloc resection rate was 98.1%.Perforations occurred during esd in 31 out of 161 patients (19.3%).All perforations were successfully treated with endoscopic closure using the hemoclips and nonsurgical management.Emergency surgery was not required in our patients.On multivariate analysis, severe submucosal fibrosis (odds ratio [or] 3.06; 95% confidence interval [ci] 1.23-7.59; p =.016) and location in the right colon (or 4.54; 95% ci 1.31-15.79; p =.017) were independent risk factors.Perforation during colorectal esd occurred in 31 patients (19.3%), but all patients had a good outcome without surgery.Submucosal fibrosis and its location are risk factors for perforation during esd.Type of adverse events/number of patients: perforation - 31 patients minor bleeding - number of patients not specified all perforations that occurred during colorectal esd were successfully managed with endoscopic closure without rescue surgery.Most cases showed minor bleeding, which were successfully managed with immediate hemostasis by hemoclipping and coagulation.

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 events 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 INJECTOR NM600/610
• Type of Device: INJECTOR AND SHEATHSET
• 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: 18684848
• MDR Text Key: 335116727
• Report Number: 9614641-2024-00337
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K153625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NM-610U-0423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• 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
• Treatment: DISPOSABLE DISTAL ATTACHMENT (D-201-15004); EVIS LUCERA ELITE COLONOVIDEOSCOPE (PCF-H290ZI); EVIS LUSERA COLONOVIDEOSCOPE (PCF-Q260AZI); OLYMPUS ESG-100 (WB991046); SINGLE USE ELECTROSURGICAL KNIFE (KD-655)
• Patient Outcome(s): Required Intervention