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 Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

An olympus technical support engineer helped the customer to troubleshoot the reported issue.During the troubleshooting, the customer was instructed to stop the process and perform an air purge to drain the basin of the fluid.Per the customer, the lcg usage displayed 2 washes and 8 days, indicating that the acecide-c was expired.The customer conducted a drain and load lcg to load the new acecide-c, high level disinfectant, into the oer-pro.Following these steps, the error code was no longer displayed.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility reported an e95 error code, no detergent solution remains, on an endoscope reprocessor.The issue occurred during reprocessing of the device.There was no patient involvement or injuries reported.No additional information has been obtained.

Manufacturer Narrative

The supplemental report is submitted to provide the result of the legal manufacturer¿s investigation.The device history record for the subject device was reviewed and it was determined that no anomalies were found that could have caused or contribute to the reported problem.The legal manufacturer performed an investigation and confirmed that the user did not replace the disinfectant solution properly which caused the error displayed by the device.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: prior to reprocessing, check the concentration of the disinfectant solution using a test strip to verify that the concentration of disinfectant solution meets the minimum recommended concentration.Replace the disinfectant solution when it fails to meet minimum recommended concentration or beyond the specified use life.

• 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: 11301108
• MDR Text Key: 232385249
• Report Number: 8010047-2021-02428
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

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: 01/13/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1