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

Model Number OER-PRO

Device Problem Failure to Disinfect (1175)

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

Event Date 08/02/2022

Event Type  malfunction  

Manufacturer Narrative

During troubleshoot via telephone, the technical support engineer emailed the quick reference guide on how to disinfect the water line.The customer did not have the correct tube (b)(4) to disinfect the water line and will order the necessary parts.Additionally, a field service engineer to the user facility to perform an in-service and provide education on the changing of the pre-filters and micron filter.The investigation is ongoing.If additional information becomes available this medical device report will be supplemented accordingly.

Event Description

The olympus technical support engineer became aware during service inquiry, the customer requested was not disinfecting the water line correctly or sufficiently.The customer has not disinfected the water line in a long time and he has not done it before and requested information on how and how often to disinfect the water line when the disinfectant is changed.No death, injury or harm was reported to olympus.

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.Approximately 12 years have passed since the device was manufactured.Based on the results of the legal manufacturer's investigation, it is likely that the reported phenomenon occurred due to the user lacking understanding of instructions for use (ifu) and did not have water supply piping disinfection hose.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): chapter 7 routine maintenance 7.3 disinfecting the water supply piping table 7.7 required items container with 2 l or larger capacity (wide-mouthed container such as a vat) filter tube (× 1) water supply piping disinfecting hose disinfection of water supply piping is required in the following cases: before using this equipment for the first time (after installation of the water filter).Immediately after replacement of the water filter.Whenever bacteria in the water supply piping is identified.Before using the device when it has not been used for more than 14 days.Olympus will continue to monitor the field performance of 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15331714
• MDR Text Key: 305501291
• Report Number: 9610595-2022-01495
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

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: Other
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2010
• 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