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); Bowel Perforation (2668)

Event Date 06/28/2023

Event Type  Injury  

Event Description

Olympus reviewed the literature titled, "endoscopic full-thickness resection versus endoscopic submucosal dissection for challenging colorectal lesions: a randomized trial" the purpose of this retrospective study was to directly compare endoscopic submucosal dissection (esd) and endoscopic full-thickness resection (eftr) for the resection of challenging colorectal lesions in a randomized trial.90 consecutive patients were included in the study, equally representing the 3 challenging lesion types.Subgroup analysis according to lesion type: 1.Lst-ng group a.Eftr group i.2 patients presented with late bleeding and were treated conservatively.B.Esd group i.A single recurrence was found and managed successfully with eftr.2.Nonlifting group a.Eftr group i.2 patients presented with local recurrence; both were treated with standard polypectomy.B.Esd group i.2 patients had a perforation during the procedure and were treated conservatively.3.Adenoma relapse/recurrence group a.Eftr group b.Esd group i.1 patient had a perforation and was treated conservatively.This medwatch report is related to the following patient identifiers: (b)(6) : cf-h180dl, (b)(6) : kd-655q, (b)(6) : kd-645l.This medwatch represents patient identifier (b)(6) , model gif-h290t.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature described "cf-h180dl" and "gif-q180".Both are evis exera ii series; therefore, "cf-h180dl" was selected as the representative device.The literature described "dual-knife and tt-knife (olympus)"; therefore, "kd-655q" and "kd-645l" were selected as representative devices.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 included additional information received from the author.B5 updated accordingly.Olympus will continue to monitor field performance for this device.

Event Description

The following additional information was received from the author: an olympus device did not cause or contribute to the adverse events described in the article.Also, no olympus device malfunction occurred during any of the events.

• 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: 18526514
• MDR Text Key: 333089126
• Report Number: 9610595-2024-01049
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• 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
• Date Manufacturer Received: 01/30/2024
• 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
• Treatment: CF-H180DL; KD-645L; KD-655Q
• Patient Outcome(s): Required Intervention