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

Model Number JF-230

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

Patient Problem Pancreatitis (4481)

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 article: "biliary guidewire facilitates bile duct biopsy and endoscopic drainage" by toshihiko higashizawa, et al.The study investigated the introduction of a guidewire through bile duct strictures and across the biliary stenosis to find out if that facilitates the transpapillary bile duct biopsy and subsequent biliary drainage.Transpapillary bile duct biopsy was attempted in 61 consecutive cases, with extrahepatic or intrahepatic bile duct strictures detected by endoscopic retrograde cholangiopancreatography (ercp).The study evaluated the success rate of endoscopic biliary drainage after performing bile duct biopsy and complications.In conclusion, the study said that the patients with bile duct strictures at ercp, the placement of a guidewire facilitates the insertion of biopsy forceps and subsequent endoscopic biliary drainage, and the biopsies were positive for cancer are more likely with bile duct cancer than pancreatic cancer.One patient suffered from acute pancreatitis that resolved within 48 h after treatment with analgesia and intravenous fluids.The authors reported using 3 different olympus devices and did not specify the olympus device used in relation to the adverse event and therefore, all will be reported.(b)(6) is for jf-230.(b)(6) is for jf-200.(b)(6) is for fb-39q-1.This is report 1 of 3 for (b)(6) is for jf-230.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation.New information added.The device history records (dhr) review could not be performed since no serial or lot numbers were provided.Olympus only ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.

• Brand Name: EVIS 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: 13545986
• MDR Text Key: 290158978
• Report Number: 8010047-2022-03089
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/23/2022

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-230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 02/24/2022
• Supplement Dates FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: No
• 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: FB-39Q-1
• Patient Outcome(s): Other