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

Model Number OER-PRO

Device Problem Filling Problem (1233)

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

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device has been returned to olympus for evaluation.During troubleshooting, the customer was instructed to change the filter.It was noted, after the customer changed the filter, the reported issue was resolved.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 cycle with the endoscope reprocessor was noted to be too long.It was indicated the amount of water supplied to the washing tank is weaker than before.There was no harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information (e1, e2, e3) received from the reporter.The event is under investigation.A supplemental report will be submitted upon receiving additional information.

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 cycle issue could not be determined.It is possible that the water flow became weaker than before because the water filter was clogged with dirt.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿chapter 7 routine maintenance 7.2 replacing the water filter (maj-824) replace the water filter at least once a month to prevent contamination of the rinse water.Note ·filter life varies depending on a number of factors including incoming water quality and use volume.·using at least a prefilter (0.45 micron or less) can extend the life of the water filter.If the prefilter is properly installed, the water filter and the prefilter should be replaced at least once every 6 months.For information on the water pre-filtration system, contact olympus.¿ 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: 15772016
• MDR Text Key: 307882082
• Report Number: 9610595-2022-03778
• 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,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2023

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: 10/12/2022
• Initial Date FDA Received: 11/10/2022
• Supplement Dates Manufacturer Received: 11/15/2022; 12/22/2022
• Supplement Dates FDA Received: 12/14/2022; 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2015
• 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