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); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/09/2022

Event Type  Injury  

Manufacturer Narrative

E1: complete establishment name -(b)(6) graduate school of medical and dental sciences.H6: health effect - clinical code 4581 is used to reflect cholecystitis, recurrent biliary obstruction, and clavien-dindo grade ii and iiia adverse events.The suspect device has not been returned to olympus.The literature is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Event Description

Olympus medical systems corp.(omsc) received a literature titled, "original article efficacy and safety of a novel anti-reflux metal stent during neoadjuvant chemotherapy for pancreatic cancer:a prospective multicenter exploratory study." literature summary background/purpose: the benefits of anti-reflux metal stents, used for treating biliary obstruction in patients receiving neoadjuvant chemotherapy (nac) for pancreatic cancer, are yet unknown.Herein, the safety and efficacy of the novel duckbill-type anti-reflux metal stent (d-arms) were prospectively evaluated for biliary drainage.Additionally, the incidence of recurrent biliary obstruction (rbo) after placement of d-arms vs conventional covered self-expandable metal stents (ccsemss) was retrospectively compared.Methods: patients who received d-arms (n = 33) for treatment of distal biliary obstruction before nac between september 2019 and january 2021 and those that received ccsemss (n = 38) between january 2013 and august 2019 were included in the historical control group.Technical and clinical successes, rate of rbo, and cumulative incidence of rbo were compared between the two groups.Results: the technical success rate was 100% for both the d-arms and ccsems groups, and the clinical success rate were not significantly different (93.9% and 89.5%, respectively; p =.68).In the multivariate analysis, d-arms was identified as the independent factor for cumulative incidence of rbo (p =.03).The cumulative incidence of rbo was significantly lower in the d-arms group than that in the ccsems group (p =.04).Conclusions: d-arms is safe and effective for patients receiving nac.Type of adverse events/number of patients adverse events throughout the follow-up period non-occlusion cholangitis -1, acute pancreatitis -2, cholecystitis -4, recurrent biliary obstruction (rbo) (stent-related) - 1 adverse events in patients with curative surgery clavien-dindo grade ii - 13 clavien-dindo grade iiia - 6 there is no report of any olympus device malfunction in any procedure described in this study.Since the literature described "tjf-260v, jf-260 v", we selected "tjf-260v" as a representative product.Since the literature described "x-suit nir", we selected "sme-210p-10060" as a representative product.The product was unknown but a representative product was chosen for processing purposes.Patient identifier is (b)(6) for tjf-260v/ae (except for rbo) patient identifier is (b)(6) for sme-210p-10060/ae (rbo) this complaint (b)(4).

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: 17187734
• MDR Text Key: 317819194
• Report Number: 9610595-2023-09212
• 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: 07/19/2023

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-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: 05/24/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/19/2023
• 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