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 Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Type  Injury  

Event Description

Olympus received the following literature article: biliary stent placement without endoscopic sphincterotomy in patients with common bile duct stones by a.Kwaw, t.Aye, k.Aye, and t.Win.The aim of study was to assess the effect of biliary stent placement without endoscopic sphincterotomy (est) in patients with (common bile duct stone) cbds.Patient had multiple procedures over the months.Forty-nine patients with cbds underwent biliary stent placement without est and complications were evaluated.Cbds(s) disappeared in 11 (22.45%) of 49 patients.Almost all of the stones which disappeared after stenting without est were 14 mm and cbd diameter 18 mm.The size of the largest stone, stone indices and diameter of cbd in the stone disappearance cases were significantly smaller than those of the stone persistence cases (p=0.003, p=0.006, p=0.004 respectively).The second time ercp aimed for complete stone clearance in the cases of stone persistence (n = 38).Among them, 21 patients (55.26%) achieved bile duct clearance; 3 patients by retrieval balloon catheter alone without est and 18 patients with est.All in all, total clearance of cbd was achieved in 14 of 49 patients (28.6%) without disruption of duodenal papilla function.Though 18 patients required est, stones were discharged easily by balloon extraction alone on 2nd ercp.Complications such as mild post-ercp pancreatitis (6.12%), stent migration (10.2%) and cholangitis (4.08%) were observed.The study concluded that temporary stent placement without est is effective for clearance of cbds while preserving the duodenal papilla function, especially in small cbds and less dilated cbd to avoid est related complications.The authors did not specify the manufacturer of the stent or extraction balloon.All procedures were performed using the olympus (b)(4).The adverse events reported in the study: 1st ercp (without est): mild post-ercp pancreatitis (3), cholangitis (2).2nd ercp (with est): mild post-ercp pancreatitis (7), cholangitis (3).3rd ercp: mild post-ercp pancreatitis (1).The author reported the patients with mild pep were treated with adequate hydration and analgesics.For the patients with recurrent cholangitis due to stent occlusion just before the time of scheduled ercp, antibiotics treatment was given and ercp procedures were repeated.The author provided two different serial numbers for the olympus devices used in the study.(b)(6): serial (b)(4 and (b)(6): serial (b)(4).This is report 1 of 2 for (b)(6): serial (b)(4.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13663727
• MDR Text Key: 288037621
• Report Number: 8010047-2022-03902
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170339967
• UDI-Public: 04953170339967
• Combination Product (y/n): N
• PMA/PMN Number: K143153
• 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: 04/26/2022

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: TJF-Q180V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2015
• 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
• Patient Outcome(s): Other