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

Model Number JF-240

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

Patient Problem Pancreatitis (4481)

Event Date 04/17/2023

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "guide wire selection (straight vs angled) in endoscopic retrograde cholangiopancreatography using a normal contrast catheter performed by a trainee: a single-center prospective randomized controlled cross-over study".Literature summary: introduction: wire-guided cannulation (wgc) during endoscopic retrograde cholangiopancreatography (ercp) is a selective biliary cannulation technique aimed at improving the successful selective biliary cannulation rate and reducing the rate of post-ercp pancreatitis (pep) incidence.This study aimed to evaluate the effectiveness of angled-tip guidewires (agw) vs.Straight-tip guidewires (sgw) for biliary cannulation via wgc by a trainee.Methods: we conducted a prospective, single-center, open-labeled, randomized, and controlled trial.Fifty-seven patients were enrolled in this study and assigned randomly to two groups (group a to s and group s to a).In this study, we started selective biliary cannulation via wgc with an agw or an sgw for 7 min.If cannulation was unsuccessful, the other guidewire was used, and cannulation was continued for another 7 min (cross-over method).Results: the selective biliary cannulation success rate over 14 min was significantly higher with an agw compared with an sgw over 14 min (57.8% vs.34.3%, p = 0.04) and for the second 7-min segment (36.4% vs.0%, p = 0.04).No significant difference was found for adverse events such as pancreatitis between the two guidewires.Conclusions: our results suggest that an agw is recommended for wgc performed by a trainee.Type of adverse events/number of patients: pancreatitis (4).The report is linked to the related patient identifier (b)(6).

Manufacturer Narrative

Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

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, a 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.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS 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: 18664150
• MDR Text Key: 334833280
• Report Number: 9610595-2024-02686
• Device Sequence Number: 1
• Product Code: FDT
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JF-240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2024
• 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
• Treatment: ANGLED-TIP OR STRAIGHT-TIP (VISIGLIDE 2); JF-240, DUODENOSCOPE; NON-OLYMPUS, DOUBLE-LUMEN INJECTION CATHETER; TJF260V, DUODENOSCOPE
• Patient Outcome(s): Other