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 Type  malfunction  

Event Description

It was reported, the endoscope reprocessor, mistakenly was using a high-level disinfectant (mckesson opa) as the 1st step instead of enzymatic detergent (flexclean).It was discovered and corrected by the customer.There were no reports of patient harm.

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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 root cause of the reported event is unable to be conclusively determined.However, the likely cause of the reported event is due to the user had insufficient knowledge on the equipment for they did not read the ifu carefully, which led to the use of high-level disinfectant instead of enzymatic detergent at manual cleaning.The event can be detected/prevented by following the instructions for use (ifu) sections which state: 6.2 precleaning, leak testing, and manual cleaning even when modified precleaning is applied, need to perform the works according to ¿endoscope precleaning continued (procedure performed at bedside immediately after patient examination)¿ on page 144.Omitting any steps according to the ¿ endoscope precleaning continued (procedure performed at bedside immediately after patient examination)¿ may lead to insufficient reprocessing.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

A correction to the aware date to 01-09-2024 for the previous submission.

Manufacturer Narrative

Additional information provided for the serial number for the device as (b)(6), updated d4 from unknown on the previous initial submission.This supplemental report is being submitted to provide this information.Please see the updates in sections: d4, h2, and h10.

• 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: 18655696
• MDR Text Key: 336070035
• Report Number: 9610595-2024-02600
• Device Sequence Number: 1
• Product Code: FEB
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2019
• 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