MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H290T

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Stenosis (2263)

Event Date 07/25/2022

Event Type  Injury  

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

Olympus reviewed the following literature titled "the feasibility and safety of endoscopic submucosal dissection of gastric lesions larger than 5cm".Background ; as the indications for endoscopic submucosal dissection (esd) for early gastric cancer have been revised, diagnostic esd has increased.However, despite the technical difficulty of esd for large lesions, the degree to which curative resection can be achieved has not been clarified.This study investigated the feasibility and safety of esd for gastric lesions larger than 5 cm.Methods ; this retrospective multicenter study included 3474 gastric lesions treated by esd from april 2012 to december 2021.We compared clinicopathological characteristics and treatment outcomes between lesions > 5 cm and lesions < 5 cm.Results ; there were 128 lesions in the > 5 cm group and 3282 lesions in the <5 cm group.In the > 5 cm group, upper location and fibrosis during esd were more common, with a lower rate of 0¿he type.Both en bloc resection rate and ro resection rate were comparable, but there was a difference in curative resection rate (65.6% in the > 5 cm group and 91.5% in the <5 cm group).The frequency of adverse events (post-esd bleeding, perforation, or stenosis) was almost similar, but delayed perforation was significantly more common (1.6% in the > 5 cm group vs.0.1% in the <5 cm group).Conclusions; about two-thirds of curative resections were obtained with esd for early gastric lesions larger than 5 cm, but delayed complications should be noted (number: umin000047725).Type of adverse events/malfunctions: bleeding.Perforation.Delayed perforation.Stenosis.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6), (gif-q260j : for evis lucera).(b)(6), (gif-h290t : for evis lucera elite).(b)(6), (kd-611l : for single surgical knife).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

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 to these fields that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16026645
• MDR Text Key: 305978398
• Report Number: 9610595-2022-05899
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 02/13/2023

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
• Device Operator: Health Professional
• Device Model Number: GIF-H290T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention