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

Model Number TJF-260V

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

Patient Problems Hemorrhage/Bleeding (1888); Pneumonia (2011); Pancreatitis (4481)

Event Date 12/26/2018

Event Type  Injury  

Manufacturer Narrative

Since the literature described "jf-260v or tjf-260v", olympus selected "tjf-260v" as a representative product.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 "endoscopic papillary large balloon dilation without sphincterotomy for users of antithrombotic agents: a multicenter retrospective study".This multicenter retrospective study was conducted to assess the safety of endoscopic papillary large balloon dilation (eplbd) without endoscopic sphincterotomy (est) as a means of removal of large bile duct stones in users of antithrombotic agents.This study analyzed 144 patients (47 users and 97 non-users of antithrombotic agents).There was no clinically significant bleeding and thrombotic events irrespective of use of antithrombotic agents.The effectiveness of the procedure did not differ across the groups users required 28% vs 29% lithotripsy, and 72% against 71% of the stones were removed in a single session both users and non-users.This study conclude that removing large bile duct stones through eplbd without est appeared to be safe for users of antithrombotic agents.¿type of adverse events/number of patients¿ bleeding from the ampulla - 1 patient [antithrombotic agents - users] pancreatitis - 3 patients [antithrombotic agents - non users] pancreatitis - 6 patients aspiration pneumonia - 1 patient 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 DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• 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: 16647254
• MDR Text Key: 312409426
• Report Number: 9610595-2023-05334
• Device Sequence Number: 1
• Product Code: FDT
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-260V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2023
• 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