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 Problems Unspecified Infection (1930); Obstruction/Occlusion (2422); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for physical evaluation.The definitive cause of the customer's experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2951238-2020-00524.

Event Description

It is reported in the literature article "minor papilla endotherapy in patients with ventral duct obstruction: identification and management" appearing in volume 85, no.2: 2017 of gastrointestinal endoscopy journal, that a patient experienced an infected pseudocyst after an endoscopic retrograde cholangiopancreatography (ercp) with cannulation of the minor papilla using an olympus duodenoscope.The treatment provided to the patient as a result of this occurrence was not reported, however it was reported that the patient did not require surgical intervention.The event occurred sometime between march 1993 and february 2015.There was no reported device malfunction.No additional information is available regarding the patient or event.

Manufacturer Narrative

This reported is being updated to provide investigation findings.The device history record (dhr) for the complaint device could not be reviewed due to no serial number being provided.Olympus does not ship any device that has not met all design and quality specifications.Conclusion: the purpose of this study is a detailed report of the pancreatic duct (pd) cannulation via the minor papilla technology, and no complaints or abnormalities have been reported for the device.

• 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: 10982707
• MDR Text Key: 220664525
• Report Number: 8010047-2020-10180
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• 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: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other