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

Model Number TJF-160VF

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The devices referenced in this report have not been returned to olympus for physical evaluation.The definitive cause of the customer's experience can not be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature article titled "endoscopic management of biliary leaks and strictures after living donor liver transplantation: optimizing techniques for successful management", published in the 19nov2016 by springer science+business media, three patients experienced bile leak and required additional treatment after undergoing an endoscopic retrograde cholangiopancreatography (ercp) to treat biliary complications post living donor liver transplantation.All ercp's were performed using one of the following olympus duodenoscopes, either tjf-160vf, tjf-q180v (for those patients with a duct to duct anastomosis), or pediatric colonoscope pcf-160/180, or single balloon enteroscope sif-q180 (for those patients with a hepaticojejunostomy).There were no malfunctions of any olympus device reported for any case described in this article.This report is being submitted conservatively to report the adverse effects experienced by three patients in the ercp group.One patient experienced clinical deterioration and required a surgical intervention.Two patients required percutaneous transhepatic cholangiography (ptc) intervention.No further patient or event details are available.

Manufacturer Narrative

This reported is being updated to provide investigation findings and additional information provided by the customer.The device history record (dhr) for the complaint device could not be reviewed as the serial number was not provided.Olympus does not ship any devices that don't meet the design and quality specifications.Conclusion: the definitive cause of the user's experience could not be determined.No device malfunction was reported.Based on the available information, the events reported are anticipated potential risks of the procedure.

• Brand Name: EVIS EXERA 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
• MDR Report Key: 11058058
• MDR Text Key: 227374453
• Report Number: 8010047-2020-10818
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• PMA/PMN Number: K024033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1