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 Problem Pancreatitis (4481)

Event Date 08/29/2022

Event Type  Injury  

Manufacturer Narrative

Since the literature described "tjf-260 v and jf-260 v" are same model description, olympus selected "tjf-260v" as a representative product.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 titled "request for biliary drainage for igg4-sc could be waived before steroid administration?".Background: in igg4-related sclerosing cholangitis (igg4-sc), the necessity of biliary drainage (bd) is unclear.In this study, we aimed to retrospectively investigate the improvement of liver damage and jaundice in cases of igg4-sc with and without bd, before starting steroids.Methods: a total of 52 patients with igg4-sc were investigated in the study.The study endpoints were the normalization rate of alkaline phosphatase (alp)/total bilirubin (t-bil) after 8 weeks of steroids, with and without bd.Results: propensity score matching was performed based on alp and t-bil, and 28 patients were included.There were 14 patients each in the bd and non-bd groups.Before initiation of steroids, the mean alp in the bd group and the non-bd group was 378/461 (p =.541); the mean t-bil was 2.5/1.8 (p =.401).Eight weeks after initiation of steroids, alp improvement rate in the bd group/ non-bd group was 69.2%/61.5% (p = 1.000), and t-bil improvement rate was 100%/100% (p = ns).Conclusions: steroids for igg4-sc could prove effective in improving liver damage and jaundice, regardless of the presence or absence of bd.Bd for igg4-sc aimed to improve jaundice may not be necessary.Type of adverse events/number of patients: mild pancreatitis 3 patients, moderate cholangitis 1 patient, acute cholangitis 6 patients.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6), (b)(6).This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

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.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: 16952653
• MDR Text Key: 315459397
• Report Number: 9610595-2023-07625
• 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
• Report Date: 07/05/2023

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: 04/19/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/05/2023
• 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