MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR; ENDOSCOPE WASHER/DISINFECTOR

Model Number OER-PRO

Device Problem Device Difficult to Maintain (3134)

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

Event Date 09/07/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus for evaluation.During communication with the customer, the customer indicated that aldahol was left in the tank and endoquick detergent in the lines.The customer indicated that they changed the filters during the down time but was not sure if water was run in line disinfect.The customer was emailed the oer-pro operation manual and directed to proper storage maintenance section.Also emailed the customer letter for proper storage and culturing of the rinse water for the oer-pro.It is unknown if the disinfectant tank needs to be cleaned or replaced or if there is bio growth, also suggested that they may want a field service engineer (fse) to check the tank.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus technical assistance center (tac), the endoscope reprocessor was not used since june, but the proper storage procedure was not followed.The customer wanted to bring the device back online for use, and wanted to know how to use it, when to change the filters, when to change the chemicals on the unit and long term/short term storage.There was no patient involvement in this event.

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 storage issue could not be determined.The instruction manual identifies the procedure for preparation for long-term storage of the device in ¿7.16 preparing the reprocessor for long-term storage¿, which may have prevented the phenomenon.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE WASHER/DISINFECTOR
• 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: 15550093
• MDR Text Key: 306433077
• Report Number: 9610595-2022-02655
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2010
• 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