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

Model Number GIF-Q260J

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Stenosis (2263); Muscle/Tendon Damage (4532)

Event Date 08/02/2022

Event Type  Injury  

Manufacturer Narrative

This report is related to the following linked patient identifiers: (b)(6).The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

Olympus reviewed the following literature titled "outcomes of endoscopic submucosal dissection in patients who develop metachronous superficial esophageal squamous cell carcinoma close to a post-endoscopic submucosal dissection scar".Literature summary: background the presence of post-endoscopic submucosal dissection (esd) scars renders complete metachronous superficial esophageal squamous cell carcinoma resection difficult.We aimed to identify the risk factors for incomplete resection of metachronous esophageal squamous cell carcinoma close to the post-esd scar by esd.Methods: we enrolled patients who developed post-esd superficial esophageal squamous cell carcinoma at hiroshima university hospital between (b)(6) 2006 and (b)(6) 2020.We analyzed the outcomes and risk factors of incomplete resection between patients whose lesions were close to (close-to group) and away from (away-from group) the post-esd scar.Procedure-related perforation was identified endoscopically or by the presence of free air on a plain chest radiograph and chest computed tomography.Endoscopic clipping was used to treat intraoperative perforation.Bleeding during esd was defined as bleeding that was controlled using hemostatic measures during the endoscopic procedure.Delayed bleeding was defined as a decrease in hemoglobin levels by 2 g/dl or more relative to the last recorded preoperative hemoglobin level or any apparent bleeding or massive melena occurring after esd.Damage to the muscle layer was defined as injury to the inner muscle ring during esd.Perforation was defined as the presence of a visible hole in the esophageal wall, exposing the mediastinal space, during the endoscopic procedure.Stenosis was defined as the requirement of balloon dilation in the treated area after esd.Results we included (b)(4) lesions.The close-to group had a significantly lower complete resection rate(b)(4).Conclusions complete resection was more difficult for lesions located on the oral side of the post-esd scar.Type of adverse events/number of patients: number of patients after propensity score matching.Bleeding during esd - (b)(4).Damage of muscle layer - (b)(4).Perforation - (b)(4).Stenosis - (b)(4).

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 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: 18750314
• MDR Text Key: 335935853
• Report Number: 9610595-2024-03655
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-Q260J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• 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: D-201-11804/UNKNOWN LOT NO.; FD-410LR/UNKNOWN LOT NO.; KD-650L/UNKNOWN LOT NO.; KD-655L/UNKNOWN LOT NO.; WB991046/UNKNOWN SERIAL NO.
• Patient Outcome(s): Required Intervention