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 Problem Perforation (2001)

Event Date 12/01/2022

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "treatment strategy for giant 0-is tumors exhibiting muscle layer traction in our hospital".Huge 0-is (stemless) tumors of the large intestine may exhibit high fibrosis and muscle traction, and are considered to be highly difficult cases of esd.In the past, muscle layer traction was one of the guidelines for stopping esd, but it is becoming a lesion that can be overcome by the progress of esd devices including traction devices and various treatment methods such as the tunnel method and pocket-creation method reported by yamamoto, hayashi et al.In our hospital, the tunnel method is the basic strategy for huge 0-is type tumors, and the double tunnel method (dt method) is used for cases with severe fibrosis and muscle layer traction in the center, and the outline of the method is explained.Type of adverse events/number of patients, intraoperative perforation - 1 patient, delayed perforation - 1 patient.This literature article requires 10 reports.The related patient identifiers are as follows: 1.(b)(6): (b)(4) for a patient in case#2, with intraoperative perforation, 2.(b)(6): (b)(4) for a patient in case, #2 with intraoperative perforation, 3.(b)(6): (b)(4) for a patient in case#2 with intraoperative perforation, 4.(b)(6): (b)(4) for a patient in case#2 with intraoperative perforation, 5.(b)(6): (b)(4) for an unknown patient with delayed perforation, 6.(b)(6): (b)(4) for an unknown patient with delayed perforation, 7.(b)(6): (b)(4) for an unknown patient with delayed perforation, 8.(b)(6): (b)(4) for an unknown patient with delayed perforation, 9.(b)(6): (b)(4) for an unknown patient with delayed perforation, 10.(b)(6): (b)(4) for an unknown patient with delayed perforation.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

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

• 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: 16440147
• MDR Text Key: 310232702
• Report Number: 9610595-2023-03259
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/07/2023

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-H290T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 04/07/2023
• 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