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

Model Number OER-ELITE

Device Problem Obstruction of Flow (2423)

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

Event Date 08/24/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation; as such, a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.

Event Description

As reported by the customer for this event by a call to the technical support center (tac) for troubleshooting, an e01 error message indicating the device basin was taking too long to fill during reprocessing.The flow of water being fed to the device was very slow.The wall filters had been changed the morning of the event.The internal filters had been changed five months previously and were not due for a change yet.However, the facility had a water main break the day before.The customer was advised to change the filter as there is a possibility that the filters can get dirty due to a water main break.

Manufacturer Narrative

Additional information has been received for this event.This supplemental report is being submitted to provide this information.Customer reported that the issue was resolved by replacing the water filter.There were no scopes involved in this event.

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, the definitive root cause of the water issue could not be determined.It is possible that the issue occurred due to user deviation from the instruction manual for replacing prefilters.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿chapter 8 replacement of consumable items 8.4 replacing the water filter (maj-824 or maj-2318) to prevent contamination of the rinse water, the water filter should be replaced every month when the prefilter is not used or every six months when the prefilter is used.¿ 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: 15595640
• MDR Text Key: 306809227
• Report Number: 9610595-2022-02041
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2023

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-ELITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 09/22/2022; 01/13/2023
• Supplement Dates FDA Received: 10/17/2022; 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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