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

Model Number GF-UCT180

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.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 3 of 3 for (b)(6): gf-uct180.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer's investigation.New information added to the following fields: h6, h10.B3 corrected.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• 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: 14218912
• MDR Text Key: 290160619
• Report Number: 8010047-2022-07105
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K093395
• 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: 05/27/2022

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: GF-UCT180
• 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: 05/11/2022
• Supplement Dates FDA Received: 05/27/2022
• 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: (B)(6)
• Patient Outcome(s): Other