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

Model Number OER-PRO

Device Problem Chemical Problem (2893)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

The root cause of the reported event cannot be determined at this time as the investigation is ongoing.If additional information becomes available this report will be supplemented accordingly.The operation manual indicates, "be sure to check the concentration of the disinfectant solution by using the separately available test strips.The disinfectant solution counter does not determine the effectiveness of the disinfectant solution.The expiration of the disinfectant solution varies depending on many factors including the time since activation, the temperature of the environment where the equipment is installed, and the number and types of endoscopes that have been reprocessed.The disinfectant solution counter does not take these and other factors into consideration.Do not add fresh disinfectant solution to the used disinfectant solution when the disinfectant solution in the device is no longer effective or the volume of the disinfectant solution in the device drops below its usable level.Drain the disinfectant solution completely and replace with fresh disinfectant solution.".

Event Description

The technical assistance center was informed that the disinfectant solution in the endoscope reprocessor was used for seven days instead of the five days that is was validated for.No death, serious injury, patient infection was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the original equipment manufacturer (oem) for mdr# 8010047-2020-08851.The original equipment manufacturer (oem) performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The oem determined the root cause of the reported ¿the disinfectant solution was not replaced properly¿ was attributed to inappropriate usage by the customer.Olympus will continue to monitor complaints for 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: 10828543
• MDR Text Key: 224687810
• Report Number: 8010047-2020-08851
• 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: 01/19/2021

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: Other
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1