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

Model Number OER-ELITE

Device Problem Device Difficult to Maintain (3134)

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

Event Type  malfunction  

Event Description

The customer reported to olympus technical assistance center (tac), the endoscope reprocessor exhibited message 082 after not being used for more than 14 days.There was no harm or user injury reported due to the event.

Manufacturer Narrative

The subject device has not been returned to olympus for evaluation.During troubleshooting, the customer indicated, the disinfectant lcg was changed earlier in the morning, although error message 082 was exhibited on the device.The customer was advised to check to see if there was any lcg in the tank and the customer confirmed there was none.The customer was then instructed to drain and load lcg and run a cycle.The customer later informed tac that the issue was resolved by an olympus technician.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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was not returned for evaluation.However, based on the results of the investigation it¿s likely the user did not read the instructions for use carefully and lacked knowledge of the equipment.The final root cause of this event was unable to be identified.The event can be detected and prevented by following the instructions for use which state: ¿chapter 9 routine maintenance 9.9 preparing the reprocessor for long-term storage when the reprocessor will be stored for more than 14 days, follow the procedure described in this section.9.10 care and maintenance after long-term storage when using the reprocessor after it has been stored for more than 14 days without being used, setting up the reprocessor, performing the reprocessing program, and performing the water supply piping disinfection are required.Perform the following procedure.¿ 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: 16852868
• MDR Text Key: 314376193
• Report Number: 9610595-2023-06969
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 06/06/2023
• Supplement Dates FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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