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

Model Number JF-260V

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

Patient Problem Pancreatitis (4481)

Event Date 01/17/2019

Event Type  Injury  

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

Olympus reviewed the following literature titled, "can iodixanol prevent post-endoscopic retrograde cholangiopancreatography pancreatitis? a prospective, randomized, controlled trial".Background: it is yet not clear whether differences in the contrast medium may affect post-endoscopic retrograde cholangiopancreatography (ercp) pancreatitis (pep).The aim of this study was to evaluate the rate of pep between high osmolality contrast medium (hocm) and iso osmolar medium (iocm) in a prospective, randomized, controlled trial.Methods: patients who were scheduled to undergo a diagnostic or therapeutic procedure under ercp guidance were included.Patients were excluded from this study if they (1) were <20 years old; (2) had acute or active pancreatitis; (3) had previously undergone ercp; (4) had surgical altered upper gastrointestinal tract anatomy; or (5) refused to be involved in this study.Results: seventy-five patients were randomly assigned to the iocm group, and 71 patients were assigned to the hocm group.Pep occurred in 27 patients (18.5%).Although there were no significant differences, the severe grade of pep was more frequent in the hocm group than in the iocm group (p = 0.08).The results of the multivariate analyses for pep were not identified as independent risk factors.Also, independent risk factors of hyperamylasemia were performing pre-cut.In subgroup analyses, hocm was an independent risk factor for hyperamylasemia.Conclusions: in conclusion, hocm may play a role in the development of pep and in pep severity grade.Type of adverse events/number of patients: post-ercp pancreatitis (mild) - 17 patients; post-ercp pancreatitis (moderate) - 8 patients; post-ercp pancreatitis (severe) - 2 patients; post-ercp hyperamylasemia - 56 patients.There is no report of any olympus device malfunction in any procedure described in this study.Since the literature described "visiglide 1", we selected "g-240-2545a" as a representative product.The product was unknown but a representative product was chosen for processing purposes.1.(b)(6) (for jf-260v).2.(b)(6) (for g-240-2545a).This report is submitted for (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to add additional information received from the author.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.

Event Description

The author confirmed the following: this event was not caused by an olympus device and there is no malfunction in olympus 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: 16721415
• MDR Text Key: 313119523
• Report Number: 9610595-2023-05969
• 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: 05/18/2023

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: JF-260V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 05/19/2023
• 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