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

Model Number JF-240

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

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

Event Date 11/01/2022

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "effect of ursodeoxycholic acid after self-expandable metal stent placement in malignant distal biliary obstruction: a propensity score¿matched cohort analysis".This multicenter retrospective study was to evaluate the efficacy of ursodeoxycholic acid (udca) in patients with self-expandable metallic stent (sems) for malignant distal biliary obstruction (mdbo) using a propensity score¿matched (psm) cohort analysis.A total of 354 patients were included (294 patients did not receive udca and 60 patients did receive udca).In the psm cohort, the sems occlusion rates in the control and udca groups were 5.5% and 18.2% at 3 months (p =.0732), 9.1% and 36.4% at 6 months (p =.0030), 14.5% and 40.0% at 12 months (p =.0049), and 18.2% and 41.8% after the complete period (p =.0119).Based on the univariate anal ysis results, udca administration (p z.0429) and 8-cm long sems (p =.13) were further assessed by multivariate analysis.In conclusion, administering udca after sems placement in patients with mdbo did not show efficacy for prolonging trbo.Patients receiving udca for more than a month might be at increased risk for sludge occlusion.Type of adverse events/number of patients [control group] (pancreatitis - 6 patients) mild - 4 patients, moderate - 2 patients, cholecystitis - 6 patients.[udca group] (pancreatitis - 2 patients) mild - 1 patient, moderate - 1 patient, cholecystitis - 5 patients, liver abscess - 1 patient.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(4) / tjf-200, (b)(4) / jf-240, (b)(4) / tjf-260v.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

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article https://doi.Org/10.1016/j.Gie.2022.10.038 provided for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Other relevant patient identifiers as follows: (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.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 events 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 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: 17242675
• MDR Text Key: 318342362
• Report Number: 9610595-2023-09590
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K954451
• 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: 07/21/2023

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: JF-240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 07/07/2023
• Supplement Dates FDA Received: 07/21/2023
• 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