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

Model Number OER-ELITE

Device Problem Failure to Disinfect (1175)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the endoscope reprocessor's water supply piping was not disinfected after the water filter was replaced.The issue was found during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

The device was not returned to olympus for evaluation.A supplemental report will be submitted 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, a definitive root cause of the reported endoscope repressor (oer) water piping not being disinfected after filter preplacement could not be determined, however, it is likely that the issue was the result of user error/ not properly following the ifu recommendations.The event can be detected/prevented by following the instructions for use which state: 4.3 mrc check setting.When this setting is activated and the mrc check result is not input before start of the following process, the reprocessor inhibits the start of the following process and message screen is displayed.- reprocessing.- leaking scope decontamination.- water line disinfection.- self-disinfection & water sampling.- detergent line disinfection.- alcohol line disinfection.Note: this setting is provided to prevent forgetting of the input of the mrc check result.The mrc check result can be input even when this setting is disabled.7.7 water line disinfection: disinfection of water line is required in the following cases.¿ before using this reprocessor for the first time (after loading of the water filter).¿ immediately after replacement of water filter.¿ before using the reprocessor if it has not been used for more than 14 days.¿ whenever bacteria in the water line is identified.The disinfectant solution stored in the reprocessor is used for disinfection of the water line.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: 18314742
• MDR Text Key: 330434871
• Report Number: 9610595-2023-19400
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170404047
• UDI-Public: 04953170404047
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K201920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/27/2023
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• 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