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

Model Number OER-PRO

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to confirm the reported issue.During the visit, the tubing between the endoquick bottle and the basin was blocked with endoquick.Fse replaced all the tubing and the components between the endoquick bottle and the basin.The equipment was repaired and verified according to specifications.No other issues were reported.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility reported that an endoscope reprocessor had a blinking symbol on the control panel, indicating the endoquick sensor was reporting no endoquick was flowing through the flow sensor.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 confirmed the subject device was shipped in accordance to specifications.Based on the results of the legal manufacturer's investigation, the phenomenon likely occurred because the required treatment for long-term storage was not conducted, causing the channel to clog with detergent.Per the instructions for use, section '7.14 preparing the reprocessor for long-term storage': "when the equipment will be stored for more than 14 days, follow the procedure described in this section".

• 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: 11097546
• MDR Text Key: 224577268
• Report Number: 8010047-2020-11160
• 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: 02/28/2021

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 Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 02/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1