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

Model Number TJF-160VF

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

Patient Problems Perforation (2001); Pancreatitis (4481)

Event Date 09/07/2021

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "artificial intelligence for automatic diagnosis of biliary stricture malignancy status in single-operator cholangioscopy: a pilot study".The aim of this study was to develop and validate a convolutional neural networks (cnn)-based algorithm for the automatic detection and differentiation of malignant biliary strictures and benign biliary lesions in digital single-operator cholangioscopy (dsoc) images.A total of 85 patients underwent dsoc (40 (47%) patients had diagnosed with benign disease whereas 45 (53%) were ultimately diagnosed with a malignant biliary stricture).Overall, the estimated model accuracy was 94.9% (95% ci, 92.4%-97.4%).The mean sensitivity and specificity of the model were 94.7% (95% ci, 90.5%-98.9%) and 92.1% (95% ci, 89.4% ¿ 94.6%).The algorithm had a mean auc of 0.988 (95% ci, 0.982-0.994).The sensitivity, specificity, ppv and npv for the detection and differentiation of malignant strictures from benign biliary disease were, respectively, 94.8%, 99.1%, 99.8%, and 80.8%.The introduction of artificial intelligence algorithms to dsoc systems may significantly increase its diagnostic yield for malignant strictures.Type of adverse events/number of patients: [malignant strictures]; cholangitis - 4 patients, pancreatitis - 9 patients, perforation - 1 patient, bacteremia - 1 patient.[benign strictures]: cholangitis - 3 patients, pancreatitis - 5 patients.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6)(tjf-160vf).(b)(6)(tjf-q180v).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

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article https://doi.Org/10.1016/j.Gie.2021.08.027 provided for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer confirms that no olympus device malfunction during any procedure described in this literature and no olympus device cause or contribute to any of the patient adverse events described in this literature.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide follow up received from the customer.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.

• Brand Name: EVIS EXERA 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: 16942238
• MDR Text Key: 315332363
• Report Number: 9610595-2023-07534
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K024033
• 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: 06/23/2023

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-160VF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 06/23/2023
• 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