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

Model Number OER-PRO

Device Problems Break (1069); Crack (1135)

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

Event Date 05/25/2023

Event Type  malfunction  

Event Description

The customer reported to the olympus field service engineer (fse) that during device maintenance, the oer-pro endoscope reprocessor was found with the yellow connector damaged and broken off.There was no patient involvement, and no harm was reported.Replacement parts were ordered, and an onsite visit by the field service engineer was scheduled.

Manufacturer Narrative

The olympus field service engineer (fse) performed an onsite repair and confirmed this issue.The fse removed and replaced the damaged yellow connector and also replaced the push plate cover unit due to cracking, according to the oem instructions and technical guide.Software attributes had been verified and confirmed to be working correctly.Equipment passed the electrical safety test, and results were attached to this service request.Device history records: the device history records for this device were reviewed, and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Complaint history review: there was a similar event complaint reported on (b)(6) from the same facility, and (b)(6) was initiated from another facility for the same device and issue.Conclusion: the root cause could not be identified; however, from the results of the investigation, it is likely that the connector was damaged by hitting a hard object or that the connector was loose, causing the cleaning tube to become unconnectable.A possible cause of a loose connector is the accumulation of loosening stress on the connector.Such events can be detected and prevented, according to the ifu in chapter 3.Inspection before use, 3.3 inspecting the connectors.Check the following for each connector: the connector should be fixed firmly.The o-rings should be free of abnormalities such as cracks, tears, or dents.Do not use the equipment if any connector seems damaged or defective.An irregularity has been detected and may interfere with reprocessing.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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17192419
• MDR Text Key: 318278125
• Report Number: 9610595-2023-09251
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/23/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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