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

Model Number OER-PRO

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 08/31/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned.Tac assisted the customer in resolving the issue and the customer was able to use the oer-pro without the detergent light being illuminated.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer contacted olympus technical assistance center (tac) stating the detergent light was illuminated on the main panel of the oer-pro after replacing the detergent container and successfully priming the detergent lines.The customer confirmed they did not perform a wash cycle.Tac had the customer execute a wash cycle and the detergent light went out.There was no patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved 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 detergent indicator issue could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿chapter 2 nomenclature and functions: 2.5 control panels.Main control panel.Detergent replacement indicator.The lamp blinks when detergent tank needs to be replaced.The error code [e95] is also displayed.Chapter 4 reprocessing operations: when the error code [e95] is displayed during the reprocessing process if detergent has run out and the error code [e95] is displayed, the equipment will stops the process.In this case, you need to start the reprocessing process from the beginning after replenishing the detergent.Follow the procedure described in section 3.5, ¿inspecting and replacing the detergent tank¿ on page 44 for replacing the detergent tank, then press start button to restart the reprocessing process.¿ 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15487278
• MDR Text Key: 306353700
• Report Number: 9610595-2022-02251
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

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-PRO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2013
• 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