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 Date 07/04/2022

Event Type  malfunction  

Manufacturer Narrative

This device is not sold in the us but a similar device is.The device is returned and an evaluation completed for it.Upon inspection of the device, it was observed that the instrument channel is clogged with foreign substances.The cleaning brush cannot be inserted.There is also a crack in the distal end rubber coating (a-rubber).Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

As reported for this event by the customer, the device was broken and stuck near the forceps opening.There is no harm to any patient or persons.

Event Description

Addendum aug 24, 2022: event occurred during reprocessing with no patient involvement.A syringe was inserted into the forceps opening, and when the fluid was pumped, part of the syringe tip flowed into the channel.Syringe tip was clogged in the device near the instrument channel port.The device was inspected prior to the issue occurring with no anomalies noted.

Manufacturer Narrative

Additional information has been received for this event.This supplemental report is being submitted to provide this information.Information on reprocessing performed at the facility: since the clogging is in the instrument channel, the air/water channel cleaning adapter is not involved.Pre-cleaning is being performed immediately after a procedure.Cleaning is performed of the outer surface of the insertion tube.Suction and air/water channels are also cleaned.Detergent used for pre-cleaning is not known.All the endoscope channels are brushed during manual cleaning with a single use brush of unknown model number.The single use brush is not re-used.Cleaning and disinfectant solutions used with the endoscope are not known.Automatic endoscopy reprocessor (aer) used to reprocess the endoscope olympus oer-6.No issues have been noted for the aer.It is not known how the endoscope is dried or stored after reprocessing.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 the instrument channel is closed with a foreign substance.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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15154882
• MDR Text Key: 302470280
• Report Number: 9610595-2022-00565
• 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,Followup
• Report Date: 10/18/2022

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: 07/18/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 08/24/2022; 09/20/2022
• Supplement Dates FDA Received: 08/25/2022; 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2022
• 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