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

Model Number OER-PRO

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to confirm the reported issue.The fse replaced the gray connector and verified there was no fluid leaks.A complete reprocessing cycle was performed successfully.The device was repaired and verified according to specifications.Software attributes were verified and confirmed.The covers of the oer-pro were not removed so an electrical safety check was not required.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility called and reported the gray scope connector was broken within the basin on an oer-pro endoscope reprocessor.No patient involvement or injuries were reported.The oer-pro was inspected prior to use to ensure no abnormalities or damage were noted.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 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 by breakage/loose of the connector.It may have disconnected the connecting tube.Stress/impact may have been added to the connector toward loose direction by the user handling, and the accumulated stress may have caused the breakage.

• 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: 10934654
• MDR Text Key: 219163058
• Report Number: 8010047-2020-09730
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• 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: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1