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

Model Number GIF-Q260J

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

Patient Problems Fever (1858); Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 12/11/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The literature article is attached for additional information.The device history record was unable to be reviewed for this device since no product malfunction was reported.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely the reported event is an accident, or a complication associated with a surgical procedure using the subject device.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.

Event Description

Olympus reviewed the following literature titled "endoscopic submucosal dissection for anastomotic lesions after colorectal surgery." abstract background: endoscopic submucosal dissection (esd) for anastomotic lesions is technically challenging.We aimed to characterize the clinicopathologic characteristics, feasibility, and effectiveness of esd for anastomotic lesions of the lower gastrointestinal tract.Method: we retrospectively investigated 55 patients with anastomotic lesions of the lower gastrointestinal tract who underwent esd from (b)(6) 2008 to (b)(6) 2021.The lesions involving one or both sides of anastomoses were classified into the unilaterally involving anastomosis (uia) or straddling anastomosis (sa) group, respectively.We collected clinicopathological characteristics, procedure-related parameters and outcomes, and follow-up data and analyzed the impact of anastomotic involvement.Results: the mean age was 62.5 years, and the median procedure duration was 30 min.The rates of en bloc resection and r0 resection were 90.9% and 85.5%, respectively.Four patients (7.3%) experienced major adverse events (aes).During a median follow-up of 66 months (range 14¿169), seven patients had local recurrence, and six patients had metastases.The 5-year disease-free survival and overall survival rates were 82.4% and 90.7%, respectively.The 5-year disease -specific survival (dss) rate was 93.3%.Compared with the uia group, the sa group had significantly longer procedure duration, larger specimen, lower rates of en bloc resection and r0 resection, and shorter disease-free survival (all p < 0.05).However, rates of aes did not differ significantly between the two groups.During the follow-up, four patients died of the cancer, and one patient died of other cancer.Conclusions: the short-term and long-term outcomes of esd for colorectal anastomotic lesions were favorable.Although with technically challenging, esd could be performed safely and effectively for lesions at the anastomoses.Type of adverse events/number of patients: death - 5 patients; perforation - 3 patients; delayed bleeding - 2 patients; febrile episode - 2 patients.This literature article requires 6 reports.The related patient identifiers are as follows: (b)(6) / gif-q260j; (b)(6) / kd-620qr; (b)(6) / kd-611l; (b)(6) / kd-650q; (b)(6) / fd-410lr; (b)(6) / d-201-11804.This medwatch report is for patient identifier (b)(6).The deaths were determined to be not reportable.There is no report of any olympus device malfunction in any procedure described in this study.

• Brand Name: EVIS LUCERA 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17175892
• MDR Text Key: 317811336
• Report Number: 9610595-2023-09137
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 06/21/2023

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-Q260J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/21/2023
• 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