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

Model Number OER-6

Device Problem Device Reprocessing Problem (1091)

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

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

B3 event date: various between august 2, 2021 to february 28, 2024.The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

Olympus was informed that the user facility staff was using water and acecide not using endoquik when cleaning with the olympus endoscope reprocessor.No patient infections or injuries reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The customer provided additional information regarding the event: - after thorough manual cleaning, water is poured into the endoquick tank and reprocessed using the reprocessor.This was done based on the facility's own judgment that there would be no problem in not using detergent (endoquick) in the reprocessor because the items were thoroughly cleaned manually.- cleaning before oer setting is basically done according to the scope cleaning manual.The cleaning brush that is made by olympus is also used.- since this event is from the past, no one involved in the incident is available to answer additional questions.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 facility staff understood that endo-quick was necessary when performing reprocessing, but they did not follow the instructions for use.The event can be prevented by implementing reprocessing in accordance with the oer-6 operation manual, section 3.5 "inspecting the remaining quantity of detergent, and replenishment" which states: "addition of detergent: warning: always use endoquick 980ml (olympus-designated detergent).If a non-designated detergent is used, the endoscope may not be properly cleaned or the predetermined sterilization effect may not be achieved." olympus will continue to monitor field performance for this device.

• Brand Name: OLYMPUS 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: 18815577
• MDR Text Key: 337667243
• Report Number: 9610595-2024-04338
• Device Sequence Number: 1
• Product Code: FEB
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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