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

Model Number OER-ELITE

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

In speaking with olympus technical assistance center (tac), the customer reported that when they are processing gif-h190 serial # (b)(6), the maj-2111 connector jig falls off the instrument channel of the scope.This scope is a trial scope provided by an olympus eam.It was confirmed the customer was using maj-2110, maj-2111 & maj-2112 connectors which was compatible.It was only the maj-2111 which fell off and the customer tried connecting 8 different maj-2111 and they all had same results.The oer endoscope reprocessor displayed a notification code when the scope was first connected, but customer couldn¿t give the exact code.The customer connected the scope to the basin again, the reprocessor accepted and the cycle started.It was concluded that the scope itself might have an issue with its instrument channel that prevents a connector from locking on properly.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that while using the endoscope reprocessor with the gastrointestinal videoscope the connector jig and connecting tube fell off the instrument channel of the scope.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.New information added to the following fields: d8, h3 and h6.Corrected fields: d9 and g2 (company representative does not apply to this event).A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was evaluated by a field service engineer and the customer's reportable malfunction was confirmed.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the user conducted reprocessing while connecting tube disconnected was due to the user reprocessed the gastrointestinal videoscope while they insufficiently confirmed connection status of the scope and connecting tube during inspection prior to use/ connector before connection.The event can be detected and prevented by handling the device in accordance with the following instructions for use: 5.7 inspecting the connecting tubes and leak test air tube before using the reprocessor, always check that there is no irregularity regarding the following points on the connecting tubes and leak test air tube.- all tubes should be free of cracks, breaks, fissures, scratches, or stains.- there should be no cracks in the lock levers of connecting tube connectors and leak test air tube connectors.- there should be no bends or breaks in the pin of connecting tubes connector and leak test air tube connector.- the tube should not be easy to disconnect once connected.If a tube has any irregularity, do not use it and replace with a new one.6.6 loading of endoscopes and accessories loading of first endoscope in the reprocessing basin warning when loading endoscopes, always be sure to disconnect cleaning accessories used for manual process from the endoscope.Otherwise, reprocessing may be insufficient.Be sure to check that the entire endoscope and all accessories are installed below the disinfectant solution level index line on the cover of float switch (long).If the endoscope and all accessories are installed above the disinfectant solution level index line, the reprocessing may be insufficient.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: 19057048
• MDR Text Key: 339578548
• Report Number: 9610595-2024-07214
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/07/2024

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2023
• 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: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE; MAJ-2111 CONNECTING TUBE