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

Model Number GIF-H180

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

Patient Problems Perforation (2001); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus medical systems corp.(omsc) received a literature titled: "impact of a routine colorectal endoscopic submucosal dissection in the surgical management of nonmalignant colorectal lesions treated in a referral cancer center".¿literature summary¿ background this study evaluated the number of nonmalignant colorectal lesions referred to surgical treatment in a tertiary cancer center that incorporated magnification chromoendoscopy and endoscopic submucosal dissection as part of the standard management of complex colorectal polyps.Methods this single-center retrospective study, from a prospectively collected database, was conducted between january 2016 and december 2019 at the division of gastrointestinal surgery and division of endoscopy, instituto do câncer do estado de são paulo, a tertiary academic cancer center.Consecutive patients aged =18 year with complex nonmalignant colorectal polyps treated by esd or surgery (elective colectomy, rectosigmoidectomy, low anterior resection, or proctocolectomy) were included in this study.All procedures were performed under general anesthesia and under carbon dioxide insufflation.Results in the study period, 1.1% of 825 colorectal surgeries were performed for nonmalignant lesions, and 97 complex polyps were endoscopically removed by endoscopic submucosal dissection.The en bloc, r0, and curative resection rates of endoscopic submucosal dissection were 91.7%, 83.5%, and 81.4%, respectively.The mean tumor size was 59 (sd 37.8) mm.Perforations during endoscopic submucosal dissection occurred in 3 cases, all treated with clipping.One patient presented with a delayed perforation 2 days after the endoscopic resection and underwent surgery.The mean follow-up period was 3 years, with no tumor recurrence in this cohort.Conclusion a workflow that includes assessment of the lesions with magnification chromoendoscopy and resection through endoscopic submucosal dissection can lead to a very low rate of abdominal surgery for nonmalignant colorectal lesions.¿type of adverse events/number of patients¿ 1) event 1- perforations during procedure- 3 patients 2) event 2-perforation after surgery- 1 patient 3) event 3- stenosis- 4 patients perforations during endoscopic submucosal dissection occurred in 3 cases, which were managed endoscopically with clips.One patient developed delayed perforation after 2 days and underwent surgery.Four patients with lesions >110mm on the rectum developed stricture and were successfully treated with endoscopic dilations.

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, a 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.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 18763948
• MDR Text Key: 336056311
• Report Number: 9610595-2024-03792
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K100584
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-H180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2024
• 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