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

Model Number OER-PRO

Device Problems Device Alarm System (1012); Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was dispatched to the user facility to confirm the reported issue.The fse observed the device and found the disinfectant tank that was half full of chemical.The fse drained the chemical and filled it with water and ran a performance cycle with no issues or errors found.The cracked lid was replaced and the device passed all the electrical safety rests.No other issues were found during the on-site visit.If additional information is obtained, a supplemental report will be filed.

Event Description

A user facility reported an e16 error on an oer-pro and a cracked lid.There was no patient harm or injury 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 instructions for use (ifu) states: ¿before using the equipment, always check that there is no irregularity regarding the following points on the lid and the lid packing.If there is any irregularity, cleaning fluid or disinfectant solution may leak out.¿ the root cause could not be conclusively determined.Probable causes that could have led to the reported event include the lid being contacted with a scope when it was closed and/or something hard hit the lid and/or chemical crack due to adhered chemical solution which was not removed.

Manufacturer Narrative

There is more information on the conclusion of the device evaluation conclusion.This supplemental report is being submitted to provide this information.Additional information was received for the event of the broken lid of the device.The lid of the device was closed on the connecting tube causing it to crack.Insufficient training on reprocessing technicians who were changed and/or newly employed due to covid-19 were considered to be a factor causing this issue.The facility has since fully trained the staff.

• 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: 10836629
• MDR Text Key: 225200384
• Report Number: 8010047-2020-08910
• 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,Followup
• Report Date: 04/29/2021

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: 10/19/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 01/13/2021; 04/08/2021
• Supplement Dates FDA Received: 02/03/2021; 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1