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

Model Number TJF-Q180V

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Perforation (2001)

Event Type  Injury  

Event Description

It was reported olympus medical systems corp.(omsc) received literature titled "technical evaluation of duodenoscope performance using a newly developed assessment tool".The study aimed to assess the reliability of newly designed assessment tool to measure the technical performance of duodenoscopes.The duodenoscope assessment tool (dat) evaluated the performance of conventional reusable duodenoscopes (tjf 180, olympus america) in 745 patients who underwent endoscopic retrograde cholangiopancreatographys (ercps) at 7 tertiary medical centers over a 6-month period.The median number of cannulation attempt was 1 (interquartile range 1-4) with overall cannulation rate of 98.1%.Adverse events included: bleeding in 17 patients; perforation in 3 patients; acute pancreatitis in 18 patients; infection in 3 patients.The study concluded the newly developed dat represents a reliable measure of the performance of a duodenoscope in patients undergoing ercp.Dat will potentially enable the objective comparison of duodenoscope performances and provide a framework for technical evaluation of other types of endoscopes.The devices were not returned to olympus for evaluation and no device serial numbers were provided.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.The risks of ercp include complications such as the following: ¿pancreatitis (inflammation of the pancreas); ¿infection of the bile ducts or gallbladder; ¿excessive bleeding, called hemorrhage; ¿an abnormal reaction to the sedative, including respiratory or cardiac problems; ¿perforation in the bile or pancreatic ducts, or in the duodenum.

• Brand Name: EVIS EXERA II 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: 10267839
• MDR Text Key: 198682023
• Report Number: 2951238-2020-00478
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170339967
• UDI-Public: 04953170339967
• 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: 06/15/2020,07/13/2020

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-Q180V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other