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 Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.This report is related to (b)(6).

Event Description

It was reported, the endoscope reprocessor was used to clean duodenovideoscopes in unknown multiple instances without attaching the cleaning adapter tube at the tip, and the improperly reprocessed devices were used to complete unspecified procedures on patients.The issue occurred during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

Correction: the serial number was inadvertently omitted from the initial report.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 event was unable to be identified.It is likely that the cause was reprocessing without carefully reading the instruction manual and using the cleaning tube (maj-2358).The survey results showed that facility staff understood that it was necessary to check the concentration of disinfectant every time they performed reprocessing, but they did not follow what was written in the instruction manual and followed the facility's own operating rules.This is thought to be due to the concentration control of the disinfectant solution.Such events can be detected and prevented according to the following instructions for use: "[oer-4 operation instruction manual] chapter 3 inspection before use 3.9 checking the concentration of disinfectant warn ¿ check the concentration of the disinfectant every time you disinfect the endoscope using an acecide checker or portable concentration checker.Failure to perform this check may result in insufficient disinfection.Also, be sure to replace the disinfectant before it loses its disinfecting effect.Chapter 4 basic procedures for cleaning and disinfecting endoscopes 4.8 installing the cleaning tube for the cleaning tube to use, please refer to the attached "cleaning tube application table ".Warn ¿ attach all specified cleaning tubes depending on the type of endoscope and perform cleaning and disinfection.If you perform cleaning and disinfection without attaching all cleaning tubes, cleaning and disinfection may be insufficient.Applicable cleaning tubes are listed in the "cleaning tube application table (for oer-4)", but new endoscope products may not be listed.If it is not listed in the application table, please contact the endoscope customer service center, our designated service center, or our branch or sales office.[cleaning tube application table ] we confirmed that maj-1500 and maj-2358 are cleaning tubes that can be applied to tjf-q290v." 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: 18794792
• MDR Text Key: 337519916
• Report Number: 9610595-2024-04148
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2020
• 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: CV-290 VIDEO SYSTEM CENTER; TJF-Q290V DUODENOVIDEOSCOPE