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

Model Number JF-260V

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

Patient Problems Hemorrhage/Bleeding (1888); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 07/07/2021

Event Type  Injury  

Event Description

It is reported in the literature titled "endoscopic radiofrequency ablation may improve overall survival in patients with inoperable ampullary carcinoma", patients experienced adverse effects during and after procedures using an evis lucera duodenovideoscope.Patients with advanced ampullary carcinoma (ac) who are unsuitable for surgery are most likely to have poor outcomes.The role of endoscopic radiofrequency ablation (rfa) in this population has not been fully defined.We aimed to assess the short- and long-term outcomes of rfa in a large cohort of ac patients.In this retrospective study, data of consecutive patients with pathologically proven ac who underwent successful endobiliary rfa and/or stent placement were collected.All patients did not undergo surgical resection.The primary outcome was overall survival (os).The secondary outcomes included clinical success and adverse events.A total of 85 patients, 50 in the rfa plus stenting group and 35 in the stenting alone group, were identified.The median os was significantly longer in the rfa group than in the stenting alone group (16.9 vs.9.8 months, p < 0.001).In multivariable cox analysis, rfa (hazards ratio 0.408; 95% confidence interval 0.235-0.706; p = 0.001) was the only independent os predictor.Eight patients with stage ii tumors, exclusively from the rfa group, survived for more than 3 years.Clinical success was comparable between the two groups (96% vs.100%, p = 0.231).Early adverse events between the two groups were similar (10% vs.2.9%, p= 0.206); however, late biliary/pancreatic stenoses occurred in three rfa patients who were successfully managed with endoscopic interventions.Endoscopic rfa appears to prolong patients' survival with acceptable safety; it may therefore be a feasible treatment option for patients with inoperable ampullary cancers.In the long-term follow-up series, three patients were considered "curative" as the endoscopy with biopsy, endoscopic ultrasonography, and computed tomography scan all demonstrated "tumor-free".However, one patient experienced distal biliary stricture after two sessions of rfa, which was managed with the placement of a fully covered metal stent.One patient showed a pancreatic orifice stricture requiring placement of multiple plastic stents.Another patient had coexistent strictures in the bile duct, pancreatic duct, and descending part of the duodenum.He obtained satisfactory symptom relief after both biliary and pancreatic stenting combined with duodenal balloon dilatation.There is no report of olympus device malfunction reported in tis study.

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant 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 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 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: 14399863
• MDR Text Key: 293696229
• Report Number: 8010047-2022-08230
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

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: 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: 04/13/2022
• Initial Date FDA Received: 05/13/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 06/08/2022
• 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): Other