MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ELITE DUODENOVIDEOSCOPE

Model Number TJF-Q290V

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

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

Event Date 02/28/2022

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 "feasibility of biliary stenting to distal malignant biliary obstruction using a novel designed metal stent with duckbill-shaped anti-reflux valve (with videos)".Objectives: anti-reflux metal stent (arms) has been used to prevent recurrent biliary obstruction (rbo) due to sludge formation or food impaction.However, the most suitable arms remains to be identified.This study aimed to evaluate the feasibility, safety, and efficacy of biliary drainage using duckbill-shaped arms (d-arms).Methods: this was a multicenter, retrospective observational study conducted at three japanese tertiary institutions.Patients with distal malignant biliary obstruction who underwent biliary stenting using d-arms were eligible to participate.Technical success, functional success, adverse event (ae), and time to rbo (trbo) were evaluated.Results: thirty patients underwent biliary stenting using d-arms from december 2018 to october 2019.The technical success rate and functional success rate were 93% and 87%, respectively.However, nonvisibility of the markers at the tip of the metal stent or spontaneous extension was occasionally observed, making biliary stenting using d-arms difficult.Early ae occurred in 10% of the patients including cholangitis and pancreatitis.During the median postprocedural observation time of 5.1 months (range, 0.8-22.8), rbo occurred in 33% and the median trbo was 261 days.As for reintervention, d-arms could be extracted in 67% of the patients with rbo.However, the stent was torn off on removal in half of the patients.Conclusions: although some modifications are still needed, d-arms was feasible and safe for biliary drainage, and sufficient trbo was achieved.Subsequent multi-institutional studies involving a larger number of patients and a longer follow-up period are warranted to validate the present results.Adverse events: postprocedural pancreatitis and d-arms was removed n=1 cholestasis improved conservatively n=1 cholangitis (mild) n=1; improved with conservative treatment cholangitis (moderate) n=1; required endoscopic treatment pancreatitis (moderate) n=1; required endoscopic treatment the article includes two reports as follows: patient identifier c22101020: tjf-260v patient identifier c22101028: tjf-q290v this is report 2 of 2 for patient identifier c22101028: tjf-q290v.

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

• Brand Name: EVIS LUCERA ELITE DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14044758
• MDR Text Key: 294482867
• Report Number: 8010047-2022-05899
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

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-Q290V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 05/30/2022
• Supplement Dates FDA Received: 06/28/2022
• 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): Required Intervention; Other