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

Event Date 06/10/2021

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled, "prospective multicenter evaluation of moving cell metallic stents in endoscopic multiple stent deployment for hepatic hilar obstruction".Background and aim: bilateral stent deployment for malignant biliary obstruction (mhbo) can be achieved using side-by-side (sbs) or stent-in-stent (sis) procedures.Compared with sbs techniques, the procedural steps of sis are technically complex due to the necessity of introducing the delivery system into a contralateral biliary tract through the mesh of the sems.To overcome this issue, a novel uncovered sems, the hilzo moving cell stent (mcs) has been released.The present study examined the technical feasibility of treating mhbo using bilateral deployment of this novel stent without dilating the mesh of the first stent to achieve insertion of the second stent within a single session, using a prospective, multicenter setting.Method: the primary outcome in the present study was the technical success rate.Technical success was defined as deployment of bilateral mcss into two or more biliary tracts using sis without a dilation device in a single-session.Results: a total of 27 patients with complications of mhbo were enrolled in this study.Bilateral sis using two mcs was successfully performed in 23 patients without using dilation devices among 27 patients (initial technical success rate; 85.2%).Median time to recurrent biliary obstruction (trbo) was 271 days.Stent dysfunction was observed in 12 patients (44.4%), and re-intervention was successfully performed in all patients without one patient who instead received best supportive care.Conclusions: the sis technique using mcs without dilation of the mesh may be technically feasible and safe.In addition, this may be useful for re-intervention.Further comparative randomized trials are needed.Type of adverse events/number of patients: acute pancreatitis n=1.Acute cholangitis n=1.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

Although the literature described "jf-260v or tjf-260v duodenoscope", olympus selected "jf-260v" as the representative model because both are evis lucera duodenoscopes.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.

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.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: 16214463
• MDR Text Key: 307790354
• Report Number: 9610595-2023-01047
• 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: 03/14/2023

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: 12/22/2022
• Initial Date FDA Received: 01/20/2023
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/14/2023
• 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