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

Model Number OER-4

Device Problem Failure to Disinfect (1175)

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

Event Date 12/04/2022

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) visited the user facility to inspect the concerned aer.The root cause of the reported issue was presumably due to long term use of a water filter.The olympus fse explained to the customer the necessity replacing the water filter regularly.Since the water filter had been replaced and the issue was considered resolved, the device is not expected to be returned.The investigation is ongoing, however, if any additional information becomes available, this report will be supplemented accordingly.Documented below is a list of the related scopes impacted: patient identifier: (b)(6) (model: cf-240ai, serial no.(b)(4).Patient identifier: (b)(6) (model: cf-240i, serial no.: (b)(4).Patient identifier: (b)(6) (model: cf-q260ai, serial no.(b)(4).Patient identifier: (b)(6) (model: gif-h260z, serial no.(b)(4).Patient identifier: (b)(6) (model: gif-q240x, serial no.(b)(4).Patient identifier: (b)(6) (model: gif-q260, serial no.(b)(4).Patient identifier: (b)(6) (model: gif-q260, serial no.(b)(4).Patient identifier: (b)(6) (model: gif-xp260n, serial no.(b)(4).Patient identifier: (b)(6) (model: gif-xp260n, serial no.(b)(4).

Event Description

Olympus (oj) was informed that the customer automatic endoscope reprocessor (aer) encountered error e73 (water supply abnormality) when mixing disinfectant, acecide-c disinfectant.It was later confirmed that the water filter of the aer had not been replaced within the recommended timeframe to ensure adequate reprocessing.Upon identifying the problem, the water filter was replaced.No patient death, injury, or impact to patient or other has been reported to olympus.

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, and since the device was not returned for evaluation, the definitive root cause of the water filter replacement issue could not be determined.It is possible that there was inadequate water filter handling or inadequate water supply channel disinfection by the user.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: "replace the water filter at least once a month periodically to prevent contamination of the rinse water." 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: 16075385
• MDR Text Key: 308473211
• Report Number: 9610595-2022-06301
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

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: OER-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/30/2023
• Supplement Dates FDA Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2020
• 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
• Treatment: SEE SECTION H10