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

Model Number OER-4

Device Problem Device Reprocessing Problem (1091)

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

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.The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.Pre-cleaning was completed immediately after the procedure and involved aspiration of water through the instrument/suction channel with a suction pump.The air/water channel was flushed with the air/water channel cleaning adapter.Manual cleaning was done after the procedure.The scope passed a leak test.Super flash detergent manufactured by adachi was used for manual cleaning.The instrument/suction channel, suction channel, and instrument channel port were brushed during manual cleaning.Manual disinfection was not done.An olympus oer-4 automatic endoscope reprocessor (aer) was used with endoquick as the detergent and acecide as the disinfectant.There were no defects with the aer.All channels were connected with tubes when setting up the aer, the concentration and expiration of the disinfectant was controlled, the disinfectant met the minimum effective concentration, the water quality was controlled.The water filter was not replaced in accordance to the instruction for use (ifu).The scope was dried using a clean towel and then stored in a cabinet without drying function at room temperature and normal air concentration.

Event Description

The customer reported to olympus that it was possible that an unknown scope model was reprocessed after it was discovered that the water filter of the olympus endoscope reprocessor (oer-4) was replaced every two months at the facility's discretion and the replacement deadline had passed.It was unknown if the scope was used clinically after reprocessing.There were no reports of patient harm.

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 oer-4 water filter not being replaced in accordance with the ifu could not be determined, however, the issue was likely due to the facility/user not reading or following the instruction manual carefully, resulting in mismanagement of the water filter replacement.The event can be detected/prevented by following the instructions for use which states: chapter 7 ¿routine maintenance¿ section 7.2 ¿replacing the water filter (maj-2318)¿ replace the water filter periodically, at least once a month to prevent contamination of the rinse water.The water filter should also be replaced whenever the error code [e01] indicating water supply insufficiency is displayed.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: 18111557
• MDR Text Key: 329228628
• Report Number: 9610595-2023-16919
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2018
• 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