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

Model Number TJF-260V

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Type  Injury  

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.

Event Description

Olympus reviewed the following literature article: predictive factors of needle-knife pre-cut papillotomy failure in patients with difficult biliary cannulation by mu-hsien lee, shu-wei huang, cheng-hui lin, et al.Deep bile duct cannulation is a key step in the success of therapeutic ercp, but it is not always achievable.It can be difficult or impossible in about 5-20% of patients.Patients with such difficulties generally have papilla stenosis, impacted stones at the tip of the common bile duct (cbd), displaced papilla opening due to a tumor or diverticulum around the ampulla, abnormal papilla position, or it has a surgically anatomically altered anatomical morphology.In such cases, the precut method is most often used as a remedy after the conventional bile duct cannula insertion method fails.It is difficult to acquire the skills required for needle-knife precut papillotomy (nkp).This study was conducted to analyze the factors of nkp failure.Adverse events: perforation, n=2, pancreatitis, n= 4, delayed bleeding, n= 13, cholangitis, n = 8.This article includes 2 reports: complaint#(b)(6) is for model tjf-240 or jf-240; we selected "tjf-240" as a representative product.Complaint#(b)(6) is for model tjf-260 or jf-260.We selected "tjf-260v" as a representative product because tjf-260 or jf-260 are not registered and it is considered tjf-260v or jf-260v is appropriate.This is report 2 of 2 for complaint#(b)(6) is for model tjf-260 or jf-260.We selected "tjf-260v" as a representative product because tjf-260 or jf-260 are not registered and it is considered tjf-260v or jf-260v is appropriate.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the author and the legal manufacturer's investigation.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.

Event Description

Additional information from the author: the author responded medical or surgical intervention was provided to the patients with adverse events however he did not specify the intervention provided.In the opinion of the author, the adverse events experienced 'have nothing to do with the olympus device.'.

• Brand Name: EVIS LUCERA 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: 14148793
• MDR Text Key: 293533505
• Report Number: 8010047-2022-06645
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 06/13/2022

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-260V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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