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

Model Number OER-PRO

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to confirm the reported issue.The fse found no errors but found a yellow connector that was missing a small piece.The fse replaced the yellow connector and three port valves.A test cycle was completed with no errors.The device passed all the functional and electrical tests.No other issues were reported.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility reported a e81 error.There was no patient involvement or injuries reported.No additional information has been obtained.

Manufacturer Narrative

The following fields were corrected: a3 (patient sex was reported as male on the initial report.However, this information was not provided and was selected in error.) this supplemental report is being submitted to provide additional information provided by the customer (b5, e2, e3), correct an error on the initial report (a3), and provide the results of the manufacturer's investigation.As a part of the investigation, a review of the device history record (dhr) and a review of the instructions for use (ifu) were conducted.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The cause of the connecting tube not connecting was a loose/broken connector.It is likely accumulated stress from the user loosened/broke the connector or the connector experienced a hard impact.The ifu contains the following statements in chapter 3.3 - inspecting the connectors: "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." olympus will continue to monitor the field performance of this device.

Event Description

Additional information was provided by the customer on 01mar2021.The customer stated they ran the morning cycle and the device stopped.There was no leaking associated with this event.The customer reported there were no patient infections or scopes with positive cultures as a result of this event.

• 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: 11373807
• MDR Text Key: 233353132
• Report Number: 8010047-2021-02966
• 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: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• 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: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1