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

Model Number TJF-Q290V

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was returned.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental will be submitted on completion of investigation or if any additional information is received.

Event Description

The company representative on behalf of the customer reported, the forceps elevator of the evis lucera elite duodenovideoscope does not move down.There were no reports of patient harm associated with the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The olympus service center confirmed the reported event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to stress of repeated use, external factors, or handling.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE 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: 15818569
• MDR Text Key: 307903290
• Report Number: 9610595-2022-04162
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q290V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 01/01/2023
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2021
• 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