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

Model Number TJF-240

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

Patient Problems Fistula (1862); Pancreatitis (4481); Liver Failure (4492); 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.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following literature titled "effect of mapping biopsy on surgical management of cholangiocarcinoma" by kojiro taura et al.This retrospective study aimed to evaluate the role of endoscopic transpapillary mapping biopsy (mb) in determining the surgical indication and procedure, and its effect on surgical radicality regarding the bile duct (bd) margin for cholangiocarcinoma (cca) patients.A total of 115 mb procedures were performed in 80 patients who underwent tumor resection.The study reported that 60 (75.0%) patients tolerated mb without any complications except pancreatitis observed in 20 (25.0%) patients.The incidence of bile leakage was significantly lower in the mb group in both the anastomotic site (5.0% vs.16.3%) and the parenchymal surface.The study concluded mb was safe and efficacious in selecting optimal surgical procedures for cholangiocarcinoma.The authors used multiple olympus devices and did not specify the devices used in relation to the adverse events experienced.Therefore, all olympus devices will be reported for the following adverse events: postoperatively, patients had mild, moderate and severe pancreatitis, post-hepatectomy liver failure, bile leakage at the anastomotic site, the parenchymal surface, and at a pancreatic fistula.This article includes 5 reports.(b)(6) - tjf-240; (b)(6) - tjf-260; (b)(6) - fb-45q-1; (b)(6) - e634044; (b)(6) - chf-b260.This is report 2 of 5 for: (b)(6) - tjf-260.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the author's opinion regarding the relatedness of the olympus device and adverse events.New information was added.The device history records (dhr) review could not be performed since no serial number was provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.

Event Description

The author provided additional information: dr.(b)(6) does not think there is a possibility the olympus device contributed to the reported adverse events.

• Brand Name: EVIS 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: 13543602
• MDR Text Key: 290450027
• Report Number: 8010047-2022-03045
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2022
• 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
• Treatment: FB-45Q-1 OR E634044, CHF-B260
• Patient Outcome(s): Other