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

Model Number TJF-240

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

Patient Problems Obstruction/Occlusion (2422); Intermenstrual Bleeding (2665); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 07/19/2022

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled, "comparison of bilateral and trisegment drainage in patients with high-grade hilar malignant biliary obstruction: a multicenter retrospective study." background: bilateral endoscopic drainage with self-expanding metallic stent (sems) can be used to effectively manage hilar malignant biliary obstruction.However, the benefits of using a trisegment drainage method remain unknown.Methods: this study retrospectively reviewed the data of 125 patients with bismuth type iiia or iv unresectable malignant strictures who underwent bilateral endoscopic drainage using semss at four tertiary centers.The patients were divided into the bilateral and trisegment drainage groups for comparison.The primary endpoint was stent patency and the secondary endpoints were technical success, technical and clinical success of reintervention, and overall survival.Results: the technical success rates of the bilateral and trisegment drainage groups were 95% (34/36) and 90% (80/89) (p=0.41), respectively, with median stent patency durations of 226 and 170 days (p=0.26), respectively.Although the technical success of reintervention was not significantly different between the two groups (p=0.51), the clinical success rate of reintervention was significantly higher in the trisegment drainage group (73% [11/15] vs 96% [47/49], p=0.009).The median survival times were 324 and 323 days in the bilateral and trisegment drainage groups, respectively (p=0.72).Multivariate cox hazards model revealed no stent patency-associated factor; however, chemotherapy was associated with longer survival.Conclusions: although no significant difference was noted with respect to stent patency, significantly higher clinical success rates were achieved with reintervention using the trisegment drainage method than using the bilateral drainage method alone.Type of adverse events/number of patients: [bilateral drainage group]: cholangitis - 1 patient, cholecystitis - 1 patient, pancreatitis - 5 patients, bleeding post-endoscopic sphincterotomy - 1 patient, stent obstruction - 15 patients.[trisegment drainage group ]: cholangitis - 6 patients, cholecystitis - 3 patients, pancreatitis - 4 patients, stent obstruction - 49 patients.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6):tjf-240 and (b)(6): jf-260v.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

Since the literature described "tjf-260, tjf-240, jf-260 or jf-260v", we selected "tjf-240"and "jf-260v" as a representative product of "evis duodenovideoscope" and "evis lucera duodenovideoscope" respectively.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 and correction to the initial with information inadvertently left out.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.

Event Description

The additional related patient identifiers are as follows: (b)(6).

• 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: 16820836
• MDR Text Key: 314076069
• Report Number: 9610595-2023-06772
• 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: 06/08/2023

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-240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 05/29/2023
• Supplement Dates FDA Received: 06/08/2023
• 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