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

Model Number OER-PRO

Device Problem Filling Problem (1233)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation as the issue is resolve.As such a definitive root cause of the reported complaint cannot be determined at this time.Evaluation will be performed based on other criteria.Supplemental report(s) will be filed as the information becomes available.

Event Description

Customer called the technical assistance center (tac) for troubleshooting as the device was receiving an e01 error for decreased flow of water.The device was running a short cycle.The customer had not changed the water filters of the device before and could not locate all the necessary parts immediately.Customer managed to change the water filters eventually and the issue of e01 error message and the short cycle were eliminated.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 11 years since the subject device was manufactured based on the results of the investigation, the reported issue was likely due to the user not understanding the maintenance method due to insufficient reading of the instructions for use.A definitive root cause could not be determined.The instructions for proper water filter replacement are addressed in the device's instructions for use.Olympus will continue to monitor field performance 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13059053
• MDR Text Key: 282634883
• Report Number: 8010047-2021-16626
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 02/01/2022
• Supplement Dates FDA Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1