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

Model Number OER-PRO

Device Problems Corroded (1131); Chemical Problem (2893)

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

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

An olympus technical assistance representative assisted the customer with troubleshooting the device.After the customer checked the device, the representative recommended replacing the switching valve.The customer inquired on filling the device with water to test and the representative advised against it.The customer later responded that the switching valve seemed to be working fine.The customer had reloaded the disinfectant and observed the device for a few days.The device appeared to be working normally.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

It was reported the acecide checker of the endoscope reprocessor indicated the disinfectant did not pass the minimum recommended concentration test.The customer reported this event occurred a day after replacing the disinfectant.The customer immediately stopped using the unit.It was further reported the bottom of the front door of the device was rusting.There was no patient involvement or impact to patient care reported for 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 (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation the cause is likely a water droplet adhered to the test strips during the disinfectant concentration test, which probably caused the concentration to be tested incorrectly.This issue is addressed in the instructions for use (ifu): "the container used in the following check, such as a beaker, and the drain connector should be completely dry.Residual moisture will affect the result.¿ olympus will continue to monitor field performance of this device.

• 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: 12108946
• MDR Text Key: 280748494
• Report Number: 8010047-2021-08347
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

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-PRO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 08/25/2021
• Supplement Dates FDA Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1