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)

Event Date 03/07/2022

Event Type  Injury  

Event Description

It is reported in the literature titled ¿carbazochrome sodium sulfonate is not effective for prevention of post gastric endoscopic submucosal dissection bleeding: a retrospective study,¿ patients experienced adverse events post-procedure(s).Background: carbazochrome sodium sulfonate (css) is conventionally administered to prevent post-endoscopic submucosal dissection (esd) bleeding in many institutions, but research on its preventive efficacy is lacking.Therefore, we investigated the risk of post-esd bleeding and the preventive efficacy of css administration.Methods: we retrospectively reviewed 304 lesions in 259 patients with gastric neoplasms who underwent esd at asahikawa medical university hospital from 2014 to 2021.In the css group, css 100 mg/day was intravenously infused with maintenance fluid replacement on postoperative days 0¿2.The risk factors of post-esd bleeding, including css administration, were investigated.Results: the overall rate of post-esd bleeding was 4.6% (14/304).The univariate analysis showed that atrial fibrillation (af), warfarin intake, heparin replacement, and tumor location in the lower third were significant risk factors for increasing the likelihood of postoperative bleeding.In the multivariate analysis, af (odds ratio [or] 3.83, 95% ci 1.02¿14.30; p¿<¿0.05), heparin replacement (or 4.60, 95% ci 1.02¿20.70; p¿<¿0.05), and tumor location in the lower third of the stomach (or 6.67, 95% ci 1.43¿31.00; p¿<¿0.05) were independent factors for post-esd bleeding.Post-esd bleeding was observed in 5.2% (9/174) of the css group and 3.8% (5/130) of the non-css group, with no significant difference between the two groups (p¿=¿0.783).Additionally, css was not shown to have preventive effects in groups with higher-risk factors, such as af diagnosis, warfarin use, heparin replacement, and tumor location in the lower third of the stomach.Conclusion: css administration was not effective for the prevention of the post-esd bleeding in the overall patient population as well as in higher-risk patients.This suggests that the administration of css for post-esd bleeding prevention may need to be reconsidered.Case with patient identifier (b)(6) reports gif-q260j.Case with patient identifier (b)(6) reports kd-655l.Case with patient identifier (b)(6) reports kd-610l.Case with patient identifier (b)(6) reports fd-412lr.There is no report of olympus device malfunction during any procedure described in this literature.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

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 b3 and g2.Information added to these fields that was inadvertently not included on the initial medwatch.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: 16013980
• MDR Text Key: 305797406
• Report Number: 9610595-2022-05740
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

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-Q260J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 02/06/2023
• 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