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

Model Number OER-PRO

Device Problem Decrease in Pressure (1490)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to confirm the reported issue.The fse found that the incoming water supply was lower than normal.The fse found the internal water filter clogged.The fse observed the filter replacement, water line disinfection, chemical replacement and heat up and one full cycle.The cycle time was back to the expected 27-28 minutes.The device was repaired and verified according to specifications.Software attributes were verified and confirmed.If additional information is obtained, a supplemental report will be filed.

Event Description

A user facility reported that the timer on an endoscope reprocessor unit was incorrect.There was no patient involvement or injuries reported.No additional information has been obtained.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The following sections were updated: g4, g7, h2, 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, it is likely the water filter clogged because it was used for more than the recommended period without replacement.The following is stated in the instructions for use and the event can be prevented: "chapter 7.2.Replacing the water filter (maj-824), replace the water filter at least once a month to prevent contamination of the rinse water.The water filter should also be replaced whenever an error code indicating water supply insufficiency [e01] is displayed.".

• 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: 11074012
• MDR Text Key: 223798204
• Report Number: 8010047-2020-11029
• 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: 02/18/2021

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: 12/02/2020
• Initial Date FDA Received: 12/27/2020
• Supplement Dates Manufacturer Received: 02/17/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1