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

Model Number OER-4

Device Problem Failure to Clean Adequately (4048)

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

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

To date, the customer have not returned the device for evaluation.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus the endoscope reprocessor, stating that when they took out the scope after reprocessing bf-1t260 with oer-4, it was confirmed that there was a highly viscous white foreign substance that looked like phlegm remaining in the circulation port filter of oer-4.Although detergent suction was not performed immediately after the test, immediately after the test, brushing was performed three times under running water using an oly disposable type cleaning brush.No foreign matter was detected at that time.The scope was reprocessed again before being used for inspection.The issue occurred during reprocessing.The procedure was unknown.There are no reports of patient or user harm associated with this event.

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 the foreign material in the water channel could not be identified, there was no physical damage where the foreign material was found.Foreign material remaining in the device was attributed to incomplete reprocessing by the customer.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿all channels of the endoscope must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.Section 3.3 precleaning.Aspirate detergent solution.Turn on the suction pump.Immerse the distal end of the insertion tube in detergent solution.Depress the suction valve and aspirate detergent solution into the instrument channel for 30 seconds (see figure 3.9).Remove the distal end of the insertion tube from the detergent solution.Depress the suction valve and aspirate air for 10 seconds.Turn off the suction pump.Instructions, operation manual for oer-4.Chapter 4 ¿basic endoscope reprocessing operations¿.Section 4.3 ¿endoscope precleaning and manual cleaning¿.Always preclean each endoscope before cleaning in this equipment.Immediately after each patient examination, clean at least the outer surfaces of the endoscope, brush around the forceps elevator and the suction channel, and clean valves according to the reprocessing procedure described in the endoscope¿s reprocessing manual.Warning: always preclean each endoscope immediately after the examination.If precleaning is not executed promptly, debris will solidify and may prevent effective reprocessing.Failure to preclean will leave excessive amounts of debris adhering to the endoscope and may compromise the effectiveness of the reprocessing.It may also result in debris accumulating in the endoscope, preventing the endoscope from working correctly.¿.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: 18384459
• MDR Text Key: 331378852
• Report Number: 9610595-2023-20242
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

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-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2016
• 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: OER-4/2624553BF-1T260/1400331