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

Model Number OER-PRO

Device Problem Residue After Decontamination (2325)

Patient Problem No Patient Involvement (2645)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

The olympus technical support center walked the customer through the steps of oer-pro maintenance and scope loading.The user facility reported that the scopes are reprocessed every 7 days.The scope channels are not brushed before loading them into the endoscope reprocessor.The customer was advised by olympus to verify that the channels are clean and clear from debris prior to loading.The customer reported that the scopes were going to be removed from service and reprocessed after brushing the channels.If additional information is received, a supplemental report will be filed.

Event Description

A user facility reported that dried brown spots were noticed under the scope in the scope cabinet.The user questioned if the oer-pro could contribute to this issue.The scope was not used on any patients.There was no patient harm or injuries 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 reported issue could have been prevented by following the instructions for use (ifu) for endoscope precleaning and manual cleaning.The root cause could not be conclusively determined.Probable causes that could have led to the reported event include that the user did not brush the scope channels before setting to oer-pro, remained tissue in channels may have been detected.

• 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: 10942184
• MDR Text Key: 219561673
• Report Number: 8010047-2020-09800
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

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 the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1