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

Model Number OER-PRO

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

An olympus representative helped the customer troubleshoot the reported issue.Olympus explained to the customer that the light on represented that the disinfectant needed to be changed.That the acecide needs to be replaced every five days or the device will fail the test strip.The user informed us that they were a new user and were not aware of all the steps.The customer was guided to find the necessary steps in the instructions for use (ifu).If additional information is obtained, a supplemental will be filed.

Event Description

A user facility reported that the lcg light was on an endoscope reprocessor, indicating the disinfectant has expired.No patient involvement or injuries were reported.No additional information has been obtained.

Manufacturer Narrative

The investigation has been completed.A device history record (dhr) review was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The suggested event is preventable by handling the device in accordance with instructions for use (ifu) on checking the disinfectant solution concentration level.The root cause could not be conclusively determined.Probable causes that could have led to the reported event include that the user did not exchange the acecide at the correct period and it was not due to abnormality of the 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: 10951446
• MDR Text Key: 226703231
• Report Number: 8010047-2020-09866
• 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: 02/03/2021

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: 11/09/2020
• Initial Date FDA Received: 12/05/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1