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

Model Number OER-PRO

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Patient Involvement (2645)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

An olympus technical support engineer helped the customer to troubleshoot the reported issue.During the troubleshooting, the customer was able to conduct a drain and load lcg to load the new acecide-c, high level disinfectant, into the oer-pro.No other issues were reported.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility reported that they closed the disinfectant drawer without loading the acecide-c containers and they were unable to reopen the drawer.There was no patient involvement or injuries reported.No additional information has been obtained.

Manufacturer Narrative

This report is being submitted to provide additional information from the manufacturer's investigation.As part of the investigation, a review of the device history record (dhr) was conducted.The dhr review did not find any anomalies or abnormalities identified during production.The device met all specifications upon release.The root cause was linked to user handling.The user closed the disinfectant drawer without loading the disinfectant bottle.Olympus will continue to monitor the field performance of this device.

• 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: 11332951
• MDR Text Key: 233369504
• Report Number: 8010047-2021-02682
• 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: 04/14/2021

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1