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

Model Number OER-AW

Device Problem Microbial Contamination of Device (2303)

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

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.All of the reprocessing accessories were without abnormality.Endorapid was used as the detergent solution and acecide was used as the disinfectant.The disinfectant was not expired and disinfection was done every month.The water filter (0.2 micron) and prefilter (1 and 0.5 micron) were replaced every month.All channels were connected with tubes when the endoscope was set up in the reprocessor.A rinse treatment system was used with abnormality.The reprocessor was dried with a sterile wipe and the lid was closed after.Endoscopes were stored in a drying cabinet and the reprocessor was stored in a clean place.During device evaluation at olympus, it was found the device passed all testing.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the endoscope reprocessor failed a culture test when being prepared for use.There was no reported patient harm or impact due to this event.

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 root cause could not be determined.The following is included in the device instructions for use ifu: "troubleshooting and repair bacteria were detected as a result of culture test of rinsing water collected from the equipment.Inspect the equipment as described in chapter, ¿inspection before use¿, preclean the scope and put it through the reprocessing process again from the beginning.If bacteria are detected again in the next culture test, contact olympus." 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: 16068687
• MDR Text Key: 308374574
• Report Number: 9610595-2022-06258
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

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-AW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2012
• 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