MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR

Model Number OER-PRO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

The referenced automated endoscope reprocessor (aer) unit was not returned to the service for evaluation.However, the service group provided the aer's water filtration system and installation overview information that the facility had previously reviewed prior to installation & use of the aer unit.Additionally, a field service engineer (fse) was requested to be dispatched to the user facility to provide an in-service in reprocessing and maintenance on their aer unit.A visit has yet to be finalized, however, the fse discussed the bacteria in the water lines issues with the user facility and advised that as long as the aer produces clean potable water and yields 20+ psi @ 4.5 gallons of water per minute to the unit, then it should meet the requirements of running the aer.If those are not met, the unit cannot be used.Based on the user facility's quality control group, the cause of the bacteria / patient infections was attributed to bacteria in the user facility's water supply.The user facility is currently investigating how to combat the reported contaminated water issue.Multiple follow-ups were made to obtain additional information from the user facility regarding the reported events but with no results.However, if additional information becomes available, this report will be supplemented accordingly.This reported event has been reported by the importer on mdr# 2951238-2019-01210.

Event Description

The service center was informed by the user facility that there is reportedly bacteria in the facility's water supply affecting the drinking water and the quality control group at the facility has determined that bacteria is passing through the automated endoscope reprocessor's (aer) internal water filter.As a result, the user facility has had to switch to a in-line bacteria filter for their drinking water supply.Patients at the facility have reported bacterial infection issues prompting the testing of their water supply.The facility noted that the bacteria in their water was a recurring issue at their facility.The patient details were not reported.

Manufacturer Narrative

The manager of respiratory services at the user facility further reported, that although their investigation is currently ongoing, the facility has ruled out the scopes and the oer-pro being affiliated with the patient infections.The facility inspected the water sources after it was observed that they were seeing an increased amount of cultures coming back positive for mycobacterium abscessus, which is a water organism.The automated endoscope reprocessor (aer), filters and the scopes have all been cultured and they have been negative.The only thing they did find is that everywhere else in the hospital has to go through a.02 micron filter and they did not have that type of filter for the water pre-scope washer.They are applying that filter now.Additionally, multiple patients were affected and the patients did not all use the same scope but the scopes have all tested negative.For the time being, they are using disposable scopes.Currently, the facility is looking at environmental factors to determine the source of the bacteria at the facility.There was around 30 cultures sent out and all equipment related to olympus came back negative.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9447464
• MDR Text Key: 184904447
• Report Number: 8010047-2019-04222
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention