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

Model Number GIF-H260

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

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

Event Date 09/22/2022

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "long-term outcome of the endoscopic submucosal dissection of early gastric cancer: a comparison between patients with and without liver cirrhosis." abstract: gastric cancer (gc) and liver cirrhosis (lc) have high incidence rates, particularly in eastern asia; however, the long-term clinical outcomes or recurrence of gc following endoscopic submucosal dissection (esd) in patients with comorbid lc remain unclear.The present study aimed to compare the long-term efficacy and safety of esd in patients with gc, with and without lc.Patients with early gc (egc) who had underlying lc and underwent endoscopic treatment (lc-egc group) were enrolled in the present study.In addition, patients with egc without lc (non-lc-egc group) were matched at a ratio of 1:3 via propensity score matching.The clinical outcomes and histopathological data of both groups were analyzed.No significant differences were observed in procedure type, complications [intraprocedural bleeding (11.8%) and perforation (0.0%)], en bloc resection rate (94.1%) and complete resection rate (100%) between the two groups.Multivariate cox regression analysis demonstrated that procedure time was significantly associated with procedure-associated bleeding [adjusted hazard ratio (hr), 1.017; 95% confidence interval (ci), 1.001-1.032; p=0.033].Furthermore, lc was significantly associated with cancer recurrence (adjusted hr, 5.482; 95% ci, 1.102-27.279; p=0.038).Taken together, the results of the present study suggest that endoscopic resection of egc in patients with lc is an effective and safe treatment method.However, further studies are required to assess recurrence.Type of adverse events/number of patients: bleeding - 13, perforation - 2, death -1, recurrence -7, this literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) :kd-610l, (b)(6) :gif-h260.This medwatch report is for patient identifier: (b)(6).The death was determined to be not reportable.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.

Event Description

The following additional information was received from the author: it was confirmed that an olympus device did not cause or contribute to any of the adverse events described in the article.In addition, an olympus device did not malfunction in any of the procedures described in the article.

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 includes a correction to d8 to provide information that was not included on the initial medwatch.In addition, new information was received from the author and added to b5.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: 16163248
• MDR Text Key: 307518840
• Report Number: 9610595-2023-00775
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K011151
• 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: 04/04/2023

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-H260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 01/19/2023
• Supplement Dates FDA Received: 04/04/2023
• 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; Other