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

Model Number TJF-260V

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

Patient Problems Abscess (1690); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following literature titled "efficacy and safety of temperature-controlled intraductal radiofrequency ablation in advanced malignant hilar biliary obstruction: a pilot multicenter randomized comparative trial".Literature summary: purpose: we aimed to evaluate the efficacy and safety of temperature-controlled intraductal radiofrequency ablation (id-rfa) for advanced malignant hilar biliary obstruction (mhbo).Methods: patients were randomly assigned to rfa group (id-rfa and bilateral plastic stent [ps]) or non-rfa group (bilateral ps) at a 1:1 ratio.Exchange to self-expanding metal stent (sems) was performed after 3 months or when premature ps occlusion occurred.Total event-free stent patency, overall survival (os), and adverse events (aes) were analyzed.Results: a total of 30 patients from three hospitals were enrolled.Stent patency and os did not differ between the two groups.In patients with each stricture length mm on both sides, stent patency was longer in the rfa group than in the non-rfa group.More patients received elective exchange to sems without ps occlusion in the rfa group than in the non-rfa group.Ae rates did not differ between the two groups.Conclusions: temperature-controlled id-rfa for advanced mhbo was safe and feasible.It could prevent premature ps occlusion within 3 months.All reported aes were mild to moderate except for three cases of severe late cholangitis related to stent occlusion in the non-rfa group.All aes were medically manageable and procedure-related death was not reported.One patient in the non-rfa group died at 21 days after enrollment due to sudden myocardial infarction , which was reported as unrelated to the procedure.In the rfa group, there was no unintended thermal injury-related severe aes.Type of adverse events/number of patients, [early adverse events (30 d)] , pancreatitis n=1, cholangitis n=8, cholecystitis n=2, fever n=5, abdominal pain n=3, liver abscess n=1, death n=1, [late adverse events], cholangitis n=10, cholecystitis n=1, liver abscess n=2.

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.This supplemental report includes information added to g2.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: 14934187
• MDR Text Key: 295354333
• Report Number: 8010047-2022-11390
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• 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
• Date Manufacturer Received: 08/19/2022
• 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