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

Model Number OER-ELITE

Device Problems Device Reprocessing Problem (1091); Filling Problem (1233)

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

Event Type  malfunction  

Event Description

A customer reported to olympus, the endoscope reprocessor was taking too long to fill the basin.This issue had been going on for a while, but the customer was adjusting to make work.There were no reported errors.The liquid chemical germicide (lcg) was also taking too long to heat up.There was no report of patient harm associated with this event.

Manufacturer Narrative

The device was not returned to olympus for evaluation.An olympus field service engineer confirmed the length of reprocessing time had increased.The pre-filtration filters and internal water filters were replaced.The disinfect lines were completed, liquid chemical germicide (lcd) was drained, the customer loaded new lcd and a cycle was completed successfully without any issues.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 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, a definitive root cause of the reported weak flow to the cleaning tank issue could not definitively be determined, however, the water flow became better when the user replaced the pre-filtration filters and the internal water, therefore, the reported issue was likely the result of a clogged pre-filtration filter which reduced the water flow into the subject equipment.The event can be detected by following the instructions for use which states: chapter 8 replacement of consumable items 8.4 replacing the water filter (maj-824 or maj-2318) note 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.The pre-filtration system may have complementary instructions for filter replacement.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: 17899848
• MDR Text Key: 325698200
• Report Number: 9610595-2023-14819
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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