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

Model Number OER-PRO

Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Date 08/26/2022

Event Type  malfunction  

Event Description

The customer reported to olympus, the endoscope reprocessor's disinfectant solution counter was not resetting.There were no reports of patient harm.

Manufacturer Narrative

The device was not returned to olympus for evaluation.The customer was instructed to verify date/time, as well as verifying that the cycle count is not set too low and days is set to 5 as the customer is using acecide.The customer resolved the issue by setting the proper cycle count and days the investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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 disinfectant solution counter not resetting could not be determined.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the initial reporter's occupation.

• 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: 15481460
• MDR Text Key: 306356980
• Report Number: 9610595-2022-02231
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2023

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: 08/26/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 12/20/2022; 01/30/2023
• Supplement Dates FDA Received: 01/19/2023; 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2016
• 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