MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR

Model Number OER-ELITE

Device Problems Partial Blockage (1065); Device Reprocessing Problem (1091)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

It was reported the endoscope reprocessor time between cycles was very long and the flow of the water supply in the reprocessing basin was weaker than before.The issue occurred during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This supplemental report is being submitted to provide the device inspection results, the results of the legal manufacturer's final investigation, the associated h6 coding, and update to field h3.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.An olympus field service engineer (fse) went on site.The device was inspected it was found that when running on program 1, the cycle took about 40 minutes to complete.The external water filter output pressure gauge readings were noted as 0.45 marking low at 20 psi during rinse.The fse replaced both external and internal filters, the pressure increased to around 50 psi and the cycle took about 30 minutes to complete.This is what the customer has been doing to improve the cycle time.The fse noticed the filter was pink in color indicating the issue was coming from the quality of the water supply delivered to all the machines.The fse discussed the water quality and requirements.The customer was using a water softener for the water supply.The customer will contact the city to inquire about the water quality and to confirm the correct water softener was being used.The device passed functional testing.Based on the results of the investigation and the information provided, root cause was likely be due to the clogged/discolored water filter, which decreased the volume of water supplied to the reprocessing bin and therefore, the total time of the reprocessing cycle was increased.The issue can be prevented by following the instructions provided in: chapter 8 replacement of consumable items, section 8.4 replacing the water filter (maj-824 or maj-2318).Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• 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: 18988423
• MDR Text Key: 338762042
• Report Number: 9610595-2024-06485
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170404047
• UDI-Public: 04953170404047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-ELITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2021
• 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