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

Model Number JF-260V

Device Problem Mechanical Jam (2983)

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

Event Date 08/02/2023

Event Type  malfunction  

Event Description

The customer reported the forceps were stuck inside the evis lucera duodenovideoscope and could not be pulled out.The issue occurred during a therapeutic procedure.There was a delay less than 10 minutes due to trying to pull the forceps out.The procedure was completed with a similar device.There was no reported patient harm or impact due to this event.

Manufacturer Narrative

The cleaning, disinfection, and sterilization (cds) was performed by the customer.The scope was not reprocessed before being sent to olympus for repair.The customer did not know what the foreign material was and there was a delay to starting precleaning.During device evaluation at olympus, it was found the complaint was confirmed and foreign material came out of the distal end and the forceps could not be inserted due to clogging of the instrument tube.Also, evaluation found the bending angle in the up direction and the play of the up/down know did not meet the standard value due to wear of the angel wire, the bending section cover adhesive was chipped/cracked, the electrical connector had discoloration due to water leakage, the forceps channel port was shaved, and multiple parts of the scope were scratched.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 and to correct h4 and h10 which has some incorrect device cleaning information.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 foreign material could not be identified nor the root cause of it although it can be presumed that the plastic stent or else got stuck while it was retrieved per additional follow up from the customer, the device was not cleaned, disinfected, and sterilized the product before it sent in for repair.There was a delay in the start of the pre-cleaning, and the air/water nozzle was flushed with air and water.The nozzle was not cleaned with lint-free cloths/brushes/sponges and the air/water nozzle was not flushed with detergent solution.The event can be detected/prevented by following the inspection method in the instructions for use: [chapter 3 preparation and inspection] [section 3.6 inspection of the endoscopic system] ¦ inspection of the instrument channel and forceps elevator 1.Confirm that the forceps elevator is lowered, then insert the endo-therapy accessory through the biopsy valve.Confirm that the endo-therapy accessory extends smoothly from the distal end.Also make sure that no foreign objects come out of the distal end.2.Extend the endo-therapy accessory approximately 3 cm from the distal end.Move the elevator control lever in the ¿¿u¿ direction and confirm that the forceps elevator is raised smoothly.3.Move the elevator control lever in the opposite direction of the ¿¿u¿ direction and confirm that the forceps elevator is lowered.4.Confirm that the endo-therapy accessory is withdrawn smoothly from the biopsy valve.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: 17672354
• MDR Text Key: 322531929
• Report Number: 9610595-2023-12641
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2008
• 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