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

Model Number OER-PRO

Device Problems Failure to Cycle (1142); Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to confirm the reported issue.The fse verified that the button was not working and replaced the main front panel to resolve the issue.No other issues were reported.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility reported the button is not working on an endoscope reprocessor during a cycle, the cycle does not start.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 investigation.A review of the device history record confirms the subject device was shipped in accordance to specifications.Based on the results of the legal manufacturer's investigation, the phenomenon likely occurred during the water filter replacement process, an event occurred in which the main control panel / sub control panel became inoperable.In addition, it is also likely the main / sub control panel came inoperable because the ic (integrated circuit chip) of the main / sub panel failed caused by the accumulation of stress due to the use of the device or accidental failure.

• 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: 11091275
• MDR Text Key: 224593694
• Report Number: 8010047-2020-11092
• 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: 02/25/2021

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: 12/03/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1