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 Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 05/12/2023

Event Type  Injury  

Event Description

Olympus reviewed the following literature "efficacy of a newly developed guidewire for selective biliary cannulation: a multicenter randomized controlled trial." abstract: background and aims: various guidewires are used for biliary cannulation, and each one has its own characteristics affecting its effectiveness.This study aimed to measure the basic properties and evaluate the effectiveness of a newly developed 0.025-inch guidewire for selective biliary cannulation.Methods: a total of 190 patients at five referral hospitals were randomly allocated to undergo selective biliary cannulation using the newly developed guidewire (ngw group, n = 95) or a conventional guidewire (cgw group, n = 95).The primary outcome was the selective biliary cannulation rate in naïve papillae.The secondary outcome was to measure the ngw basic properties, compare them with those of the cgw, and analyze the importance of basic property differences.Results: there were no significant differences between the groups in the baseline characteristics.The primary outcome (75.8% vs.84.2%, p = 0.102) and adverse event rate (6.3% vs.4.2%, p = 0.374) were similar in both groups.However, compared with the cgw group, the ngw group showed a higher number of ampulla contacts (2.58 vs.2.02, p = 0.011) and longer cannulation time (216.5 vs.135.1 s, p = 0.016).Furthermore, the ngw group had higher maximum friction (34.6 ± 1.34 vs.30.2 ± 4.09), lower stiffness, and better elastic resiliency.In the multivariate analysis, a curved-tip gw (or = 0.26, 95% ci 0.11¿0.62, p = 0.002) and normal papillary shape (or = 0.39, 95% ci 0.17¿0.86, p = 0.021) were contributing factors for successful selective biliary cannulation.Conclusions: the ngw group had high friction and low stiffness, characteristics affecting biliary cannulation.Clinically, the ngw group had similar success and adverse event rates as the cgw, but they showed a higher number of ampulla contacts and longer cannulation time.¿type of adverse events/number of patients¿ event1: pep (post-ercp pancreatitis) (10 patients) event2: hyperamylasemia (9 patients) event3: cholecystitis (3 patients) all adverse events were mild and resolved with supportive care.No bleeding or perforation was observed in any of the patients.

Manufacturer Narrative

This report is related to the following linked patient identifier: (b)(6).Since the literature described "duodenoscope (tjf or jf 260)", olympus selected tjf-260v as a representative product.The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.The literature article doi.Org/10.3390/jcm12103440 provided for additional 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 additional information received from the author.B5 updated accordingly.Olympus will continue to monitor field performance for this device.

Event Description

An olympus device did not cause or contribute to the adverse events described in the article.Also, it was confirmed that there was no malfunction of an 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: 18765988
• MDR Text Key: 336056550
• Report Number: 9610595-2024-03817
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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: 03/25/2024
• 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: GUIDEWIRE; SPHINCTEROTOME V (KD-V411M-0725)
• Patient Outcome(s): Other