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

Model Number TJF-Q180V

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

Patient Problems Hemorrhage/Bleeding (1888); Pancreatitis (4481)

Event Date 03/29/2022

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Olympus reviewed the following literature titled "endoscopic ultrasound plus endoscopic retrograde cholangiopancreatography based tissue sampling for diagnosis of proximal and distal biliary stenosis due to cholangiocarcinoma: results from a retrospective single-center study." abstract: differentiating between benign and malignant biliary stenosis (bs) is challenging, where tissue diagnosis plays a crucial role.Endoscopic retrograde cholangiopancreatography (ercp)- based tissue sampling and endoscopic ultrasound (eus) with fine-needle aspiration (fna) or biopsy (fnb) are used to obtain tissue specimens from bs.The aim of this retrospective study was to evaluate the diagnostic yield of eus-fna/b plus ercp with brushing or forceps biopsy in bs.All endoscopic procedures performed in patients with bs at our gastroenterology unit were reviewed.The gold standard for diagnosis was histopathology of surgical specimens or the progression of the malignancy at radiological or clinical follow-up.A total of 70 endoscopic procedures were performed in 51 patients with bs.Final endoscopic diagnosis was reached in 96% of the patients and was malignant in 61.7% and benign in 38.3% of cases.Sensitivity, specificity, and diagnostic accuracy were 73.9%, 100%, and 80%, respectively, for eus-fna/b; 66.7%, 100%, and 82.5% for ercp; and 83.3%, 100%, and 87.5% for both procedures carried out in the same session.The combination of eus and ercp tissue sampling seems to increase diagnostic accuracy in defining the etiology of bs.Performing both procedures in a single session reduces the time required for diagnostic work-up and optimizes resources.This article includes 3 olympus devices and the reported adverse events: (b)(6): tjf-q180v, the literature described "tjf-180", we selected "tjf-q180v" as a representative product.(b)(6): fb-26n-1.(b)(6): gf-uct180.Mild post-ercp bleeding -(1) mild post-ercp pancreatitis -(1) this report is 1 of 3 for (b)(6): tjf-q180v, the literature described "tjf-180", we selected "tjf-q180v" as a representative product.

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 EXERA II 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: 14218886
• MDR Text Key: 290160793
• Report Number: 8010047-2022-07102
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170339967
• UDI-Public: 04953170339967
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• 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: TJF-Q180V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/27/2022
• 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
• Treatment: UNKNOWN SERIALS: FB-26N-1, GF-UCT180
• Patient Outcome(s): Other