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

Model Number OER-PRO

Device Problems Device Alarm System (1012); Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) went through basic troubleshooting procedures to clear the error, but efforts did not work.The fse ordered the necessary parts to repair the issue and was dispatched.During the on-site visit, the fse noticed that the gray channel connector in the machine was missing the center piece and noticed that the circulation port mesh screen was clogged with debris.The fse ran the maintenance tool and found the channel pressure varying greatly below the 180-200 range.The fse cleaned the filter mesh screen and replaced the grey connector.The device was repaired according to specifications and electrical safety check was performed.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility reported an e22 error on an endoscope reprocessor.The issue occurred during a cycle.No patient involvement or injuries were reported.No additional information has been obtained.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g4, g7, h2, h3, h4, h6, and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the broken connector found during the device evaluation is the reportable malfunction.It is likely the connector breakage was due to accumulating stress toward the loosening direction and / or hitting a hard object to the device.Per the legal manufacturer, the other issue identified in the initial report (e22 error) has no potential to cause or contribute to death or serious injury if it were to recur.A review of the instruction for use confirms the issue (broken connector) is detectable in section 3.3.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.

• 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: 11049351
• MDR Text Key: 225929907
• Report Number: 8010047-2020-10764
• 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: 02/10/2021

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1