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

Model Number OER-ELITE

Device Problem Device Reprocessing Problem (1091)

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

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the endoscope reprocessor was not reprocessed correctly by a customer.The issue occurred during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of 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.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the malfunction would likely be that olympus was unable to resolve the user¿s concerns.Therefore, the user possibly conducted reprocessing with incorrect steps.The event can be detected/prevented by following the instructions for use (ifu) which state: chapter 6 reprocessing operations 6.2 precleaning, leak testing, and manual cleaning endoscopes must be first cleaned according to one of two ways, prior to reprocessing in the oer-elite: precleaning and manual cleaning immediately after each patient examination, perform bedside precleaning, clean the outer surfaces of the endoscope, brush the suction channel, flush and rinse all channels according to the step-by-step cleaning procedure described in the endoscope¿s reprocessing manual.Complete both the prescribed bedside and manual cleaning procedures.After the endoscope undergoes full manual cleaning, it can be reprocessed in the oer-elite.The oer-elite then provides supplemental cleaning and high-level disinfection.Modified precleaning and manual cleaning immediately after each patient examination, perform the bedside-precleaning and manual-cleaning procedures for the endoscope as described in the endoscope¿s reprocessing manual, but with the modifications described in this section.This section describes: 1) how certain steps performed at the bedside can be performed using less fluid volume, and using water in place of detergent, 2) how the manual steps for brushing the channels and the elevator (if applicable), and for cleaning the outside surfaces of the endoscope are unchanged, and 3) how the requirement to connect certain flushing tubes, and the need to manually flush detergent and rinse water through the channels can be omitted.The functions of the modified/omitted steps are covered by the cleaning process of the oer-elite.After cleaning the endoscope following this modified procedure, the endoscope can be placed in the oer-elite.The oer-elite completes the cleaning process and follows this with high-level disinfection.Olympus will continue to monitor field performance for this device.

Event Description

While conducting an in-service, the olympus representative observed the tech placing the scope into a water filled sink for the leakage test process, it was noticed that the leak tester was not first attached and turned on in order to pressurize the scope.There appeared to be other inconsistencies in the manual cleaning process.

• 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: 18991006
• MDR Text Key: 338789772
• Report Number: 9610595-2024-06546
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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