MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number TJF-260V

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

Patient Problems Abdominal Pain (1685); Extreme Exhaustion (1843); Inflammation (1932); Urinary Frequency (2275); Weight Changes (2607); Pancreatitis (4481)

Event Date 04/27/2018

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "evaluation of a 12-mm diameter covered self-expandable end bare metal stent for malignant biliary obstruction." literature summary: this study aimed to evaluate the efficacy of a novel 12-mm-diameter covered, self-expandable end bare metal stent (12-mm cseems).A total of 99 patients with unresectable malignant distal biliary obstructions were enrolled.Univariate cox analysis demonstrated that risk of mortality was lower in patients with chemotherapy (hr, 0.610; 95 % ci, 0.4041 ¿ 0.92560; p = 0.020), multivariate cox hazard analysis demonstrated that risk of mortality was lower in the females (hr, 1.974; 95 % ci, 1.23762 ¿ 3.14849; p = 0.004).Recurrent biliary obstruction (rbo) was significantly lower in the 12-mm-cseems group than in 10-mm fcsems group.Early and late adverse events were significantly lower in 12-mm-cseems group than in 10-mm fcsems group.The 12-mm cseems showed a longer time to rbo (trbo) compared with the widely used 10-mm fcsems, with a similar incidence of adverse events.Therefore, this stent may be safe and effective for managing malignant distal biliary obstruction.Type of adverse events/number of patients: abdominal pain, cholangitis, cholecystitis, pancreatitis, hyperamylasemia, death.The death described in the literature is not being reported as it is unrelated to the olympus device.There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

H6 code: urinary frequency, extreme exhaustion and weight changes are used to code hyperamylasemia amd inflammation is used for cholecystitis.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

Additional information received identified from the author stated that the olympus device did not cause or contribute to the adverse events described in the literature "evaluation of a 12-mm diameter covered self-expandable end bare metal stent for malignant biliary obstruction.".

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the author regarding the reported event.New information added to the following.

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 and/or lot 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.Therefore, the root cause cannot be determined.This supplemental report includes a correction to b3 to provide information that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17412388
• MDR Text Key: 319954640
• Report Number: 9610595-2023-10751
• Device Sequence Number: 1
• Product Code: FDT
• 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,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2023

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: 07/03/2023
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: 08/31/2023; 10/05/2023
• Supplement Dates FDA Received: 09/21/2023; 10/05/2023
• 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