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

Model Number GIF-HQ190

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

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Melena (4480)

Event Date 02/20/2022

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "evaluation of antireflux mucosectomy for severe gastroesophageal reflux disease: medium-term results of a pilot study".The aim of our study was to evaluate the medium-term efficacy of the antireflux mucosectomy (arms) technique for patients with severe gastroesophageal reflux disease (gerd) symptoms (proton pump inhibitors (ppi)-treatment-dependent or ppi treatment-resistant gerd).A total of 13 patients were included.After 24 months arms, gerd symptoms were significantly improved for the 11 remaining patients, for whom median gerd-hrql score decreased from 33 (iqr 26-42) to 3 (iqr 0-7) (p = 0:001).Heartburn, regurgitation and dysphagia had disappeared for all the patients at 24 months.Despite these short-term adverse events, the overall patient satisfaction in reducing gerd symptoms was very good, 9/11 patients (81%) were willing to repeat arms if needed.In this pilot study, arms of esophagogastric junction (egj) was a feasible and effective medium-term technique for gerd treatment with a relatively high morbidity rate.Type of adverse events/number of patients.Intraoperative bleeding - 13 patients.13 patients had intraoperative bleeding and the following complications, respectively.Melena - 1 patient.Melena & pain - 1 patient.Immediate or postoperative thoracic or abdominal pain - 7 patients.Intermittent pain - 1 patient.Egj stenosis - 1 patient.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) (fd-410lr).(b)(6)(gif-hq190).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 doi: https://doi.Org/10.1155/2022/1606944 provided 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 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 EXERA III 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: 16895139
• MDR Text Key: 314825363
• Report Number: 9610595-2023-07240
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131780
• 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: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2023
• 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): Other; Required Intervention