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

Model Number OER-ELITE

Device Problem Device Reprocessing Problem (1091)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

It was observed during troubleshooting, that the connector (maj-2127) was not correctly connected to the endoscope reprocessor.There were no reports of patient involvement.

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

While speaking with the olympus technical assistance center (tac), the technician confirmed, the problem.The customer was instructed on how to correctly connect the tubes.Therefore, the problem was solved.

Manufacturer Narrative

This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation.Corr 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 to olympus for inspection.However, there was no error with the equipment.The customer was not correctly connecting tubes.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely, that leak test air tube was not connected correctly, during reprocessing occurred, due to the user did not read the instructions for use carefully.The event can be prevented, by following the instructions for use, which state: chapter 6: reprocessing operations: 6.6: loading of endoscopes and accessories: attaching the connecting tubes to first endoscope, connection guide of first endoscope, when connection guide setting is activated, connection guide screen is displayed, after inputting scope id with rfid.Connection guide screen provides the information about the type of connecting tubes required for the endoscope.And the location of connectors that these connecting tubes are connected.The below figure is example case.If endoscope with two instrument channel ports is set, it is required, to connect b2.Refer to the connection guide information and ¿list of compatible endoscopes/connecting tubes ¿.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: 18937788
• MDR Text Key: 338187697
• Report Number: 9610595-2024-05871
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170404047
• UDI-Public: 04953170404047
• Combination Product (y/n): N
• PMA/PMN Number: K201920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: OER-ELITE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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
• Treatment: MAJ-2127/ CONNECTOR