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

Model Number TJF-Q190V

Device Problem Mechanical Jam (2983)

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

Event Date 10/25/2022

Event Type  malfunction  

Event Description

The customer reported the evis exera iii duodenovideoscope failed out of the box at install.The elevator would not work or move down at all.There was no reported patient harm or impact due to this event.

Manufacturer Narrative

During device evaluation at olympus, it was found the distal end plastic cover was scratched, the bending section cover was peeling on the insertion tube side, the insertion tube had minor scratches, the light guide tube had minor scratches, and the angle wires were scratched.No leaks were found.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was evaluated where the customers complaint was not confirmed.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, a definitive root cause could not be determined.However, it is likely that foreign material got stuck in the forceps elevator causing the event.The following is included in the instructions for use (ifu): "inspection of the endoscope inspection of the forceps elevator mechanism straighten the bending section.Move the elevator control lever slowly all the way in the opposite direction of the ¿ u¿ direction.While observing the forceps elevator at the distal end of the insertion section, slowly move the elevator control lever in the ¿ u¿ direction until the elevator control lever stops.Confirm that the lever can be operated smoothly and that the forceps elevator is raised smoothly.Confirm that the forceps elevator remains stationary when pushed from behind while holding the elevator control lever stationary.Move the elevator control lever slowly all the way in the opposite direction of the ¿ u¿ direction.Confirm that the lever can be operated smoothly and that the forceps elevator lowers smoothly." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 15832915
• MDR Text Key: 307772880
• Report Number: 9610595-2022-04346
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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-Q190V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 03/06/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1