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

Model Number TJF-Q180V

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

Patient Problem Pancreatitis (4481)

Event Date 01/04/2022

Event Type  Injury  

Manufacturer Narrative

The serial number of the subject device was not specified.Therefore, it is unknown if the device has been returned to olympus for evaluation.Olympus will reach out to the authoring physician to obtain clarifying information.The cause of the patients' outcome cannot be determined at this time.If new and relevant information is received, this report will be supplemented accordingly.

Event Description

Olympus received a literature titled ¿preventive effect of tacrolimus on patients with post-endoscopic retrograde cholangiopancreatography pancreatitis.¿ the prospective pilot study aimed to determine the efficacy of tacrolimus, a calcineurin inhibitor, in preventing post-ercp pancreatitis (pep).A total of 99 patients were included in the study, of which 48 patients were included in the tac group, while 51 patients were included in the control group.There were no differences in the baseline characteristics between the tac group (n=48) and the control group (n=51).Pep was observed in 12 patients (12.1%), four out of 48 patients (8.3%) in the tac group compared to eight out of 51 patients (15.7%) in the control group.The mean trough tacrolimus level in patients who developed pep was significantly lower (p<0.05).The study concluded that the oral tacrolimus at a cumulative dose of 4 mg safely prevents pep.Further randomized controlled studies are warranted to establish the role of tacrolimus in this context.It was reported that 12 patients developed post-ercp pancreatitis, and three patients developed post-procedure cholangitis.

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.Also, information added to d8.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 16031094
• MDR Text Key: 305973861
• Report Number: 9610595-2022-05936
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

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: TJF-Q180V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 02/14/2023
• 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