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 Unspecified Infection (1930)

Event Type  Injury  

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.

• 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: 10979547
• MDR Text Key: 220638728
• Report Number: 2951238-2020-00524
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2020,12/09/2020

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-160VF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other