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

Model Number GIF-HQ290

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

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

Event Date 08/07/2022

Event Type  Injury  

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.

Event Description

Olympus reviewed the following literature titled "efficacy and safety of one-step knife compared to conventional insulated-tip knife for endoscopic submucosal dissection: a preliminary study with prospective data collection and retrospective review." this prospective data collection and retrospective review, aimed to compare the insulated tip type of one step knife (osk) and conventional knife (ck) in terms of procedure time and complication rate.A total of 203 patients were included in the study (osk (n = 102) & ck (n = 101).The procedure time of esd was shorter in osk group all situations except for the resection of submucosal cancer.The procedure time for each location was more reduced in the body (median 14 vs.19 min p<0.01) than the antrum (median 10 vs.14 min, p=0.01) in the osk group.The complications were not significantly different between both groups.In summary, osk is a safe and effective knife compared to conventional knives and showed faster procedure time, especially in gastric body lesions.Type of adverse events/number of patients: bleeding - 8 patients.Perforation - 3 patients.All complications were controlled by endoscopic management.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) (for kd-611l).(b)(6) (for gif-hq290).There is no report of any olympus device malfunction in any procedure described in this study.

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 events 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: 16625183
• MDR Text Key: 312112609
• Report Number: 9610595-2023-05119
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 05/03/2023

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-HQ290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 05/03/2023
• 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
• Treatment: SINGLE USE ELECTROSURGICAL KNIFE - LOT UNKNOWN.
• Patient Outcome(s): Required Intervention; Life Threatening