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

Model Number OER-PRO

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

The olympus field service engineer (fse) evaluated the device at the user facility, it was determined that the user did not experience an e51 message.The user stated prior to the fse visit, she spoke with the olympus technical assistance center about the issue and referenced the previous repair with e51 issue.The user clarified that the issue they been having was that one of the grey connectors had become ¿unscrewed¿ from the rest of the device connectors.The fse replaced the grey connectors and once completed, the device was tested and passed the required testing and specifications.Root cause of the reported failure is unknown.Likely root cause could be due to maintenance issue and or handling issue of the device.

Event Description

It was reported that during reprocessing, an e51 leaking detected with no fluid found message occurred on the oer-pro device.The user conveyed that the device was not in use until the site visit inspection of the unit.There was no patient involvement on this report.No user harm or injury was reported.

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 instructions for use (ifu) states: ¿check the following for each connector.The connector should be fixed firmly.The o-rings should be free of abnormalities such as cracks, tears, or dents.¿ the root cause could not be conclusively determined.Probable causes that could have led to the reported event include that the connector unit was broken for the connector was loosen or broken.The breakage of the connector may have been due to stress, which was added to the connector by the user handling, and the accumulated stress toward loose direction.

• 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: 10482028
• MDR Text Key: 221568013
• Report Number: 8010047-2020-06106
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1