MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-HQ190

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

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

Event Date 11/12/2021

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 "efficacy and safety of endoscopic submucosal dissection for superficial gastric neoplasms: a latin american cohort study" background/aims: endoscopic submucosal dissection (esd) is the preferred technique for treating early gastric cancer (egc).However, very few studies have been conducted in south america.This study aimed to assess the efficacy and safety of esd for egc.Methods: we analyzed data from a prospective cohort from 2013 to 2020.A total of 152 superficial gastric neoplasms that fulfilled the absolute or expanded criteria for esd were included.Outcomes were en bloc, r0, and curative resection rates, incidence of adverse events, and length of procedure.Results: the age of the enrolled patients was 68.4±11.3 years.The number of included patients based on the absolute and expanded indications was 150 and 2, respectively.En bloc, r0, and curative resections were achieved in 98.0%, 96.1%, and 89.5% of the cases, respectively.Bleeding and perforation were reported in 5.9% and 6.6% of the cases, respectively.Histopathological examination revealed low-grade dysplasia, high-grade dysplasia, well-differentiated adenocarcinoma, and poorly differentiated adenocarcinoma in 13, 20, 117, and 2 cases, respectively.Conclusions: our study shows that esd performed by properly trained endoscopists in reference centers is safe and effective, with comparable therapeutic outcomes to those reported in the eastern series.Type of adverse events/number of patients: immediate perforation - 9 patients.Delayed perforation - 1 patient.Intraprocedural bleeding - 3 patients.Delayed bleeding - 6 patients.This literature article requires 4 reports.The related patient identifiers are as follows: (b)(6).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 literature article inadvertently omitted from the initial medwatch report.

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

• Brand Name: EVIS EXERA III 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: 16292645
• MDR Text Key: 308734203
• Report Number: 9610595-2023-01732
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K131780
• 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,Followup
• Report Date: 04/17/2023

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-HQ190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 02/03/2023; 04/05/2023
• Supplement Dates FDA Received: 02/03/2023; 04/17/2023
• 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