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

Model Number GIF-H290

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

Patient Problem Perforation (2001)

Event Date 06/02/2021

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled, "a pilot human study on newly designed closure clips in endoscopic closure of giant gastrointestinal perforation using a continuous closing method" background: a large gastrointestinal perforation is a serious and even life-threatening clinical condition.Current endoscopic techniques for closing large gastrointestinal perforation have limitations.Building upon our recent findings in a porcine model, this pilot human study aimed to evaluate the safety, feasibility, and effectiveness of a novel endoscopic technique using newly designed closure clips for closure of giant gastrointestinal perforation.Methods: a total of 18 patients who underwent endoscopic submucosal dissection (esd) and developed giant gastrointestinal perforation>2 cm in diameter were enrolled in this study.The newly designed closure clips, consisting of a sewing clip and knotter, were applied in endoscopic closure of the gastrointestinal perforations using a continuous suturing method.The safety, feasibility, and effectiveness were subsequently assessed in these patients.Results: endoscopic closure of the giant perforation was achieved in all patients.In evaluation of safety and effectiveness of this technique with the new closure clips and the continuous suturing method, no obvious intraoperative complications (e.G., bleeding, abdominal infection) occurred in the studied patients.Furthermore, on 1-month follow-up gastric endoscopy, all the patients showed complete closure of the gastrointestinal perforations, and no clinical signs of specific abnormalities or symptoms were observed.Conclusion: this novel technique has been shown to be safe, effective, and feasible for the treatment of giant gastrointestinal perforation.Type of adverse events/number of patients.Gastrointestinal perforation - 18 patients.There is no report of any olympus device malfunction in any procedure described in this study.

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.

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 new information received from the author that was not previously reported.B5 has been updated to reflect the new information received.Olympus will continue to monitor field performance for this device.

Event Description

The following additional information was provided by the author: the purpose of this literature article was to introduce a new endoscopy technique and new instruments.There was no olympus device malfunction during any of the procedures described in the article.In addition, an olympus device did not cause or contribute to any of the adverse events described in the article.

• 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: 16270402
• MDR Text Key: 308440076
• Report Number: 9610595-2023-01516
• 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,Followup
• Report Date: 04/19/2023

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-H290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 04/19/2023
• 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): Hospitalization; Required Intervention