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

Model Number OER-PRO

Device Problem Failure to Reset (1532)

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

The reported problem was resolved with the assistance of olympus technical support via the phone.A device was not returned to olympus for evaluation.To resolve the lcg light blinking, the user completed a drain and load lcg cycle again to reset the indicator.It was learned that the end users performed a drain lcg the previous week and the load lcg was not performed until the following week.After performing the load lcg and priming the system, the lcg light went out and the issue was resolved.

Event Description

A user facility reported to olympus that the acecide was replaced but the lcg light continued to blink on the oer-pro.There was no patient involvement associated with the reported problem.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.The dhr for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.The legal manufacturer determined that the event was due to user handling (the detergent replacement indicator was on because the device was turned on without replacing the detergent tank).The device instructions for use contains the following: "detergent replacement indicator: the lamp blinks when detergent tank needs to be replaced.Therefore, the device has to be turned on after replaced the detergent tank.

• 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: 10078317
• MDR Text Key: 222564851
• Report Number: 8010047-2020-02835
• 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: 09/28/2020

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: 05/03/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1