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

Model Number OER-PRO

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

The health professional reported that, when the issue occurred, she was attempting to a drain/loadlcg due to issues with the test strips.The user neglected to select the loadlcg/function start on the sub control panel of device.The customer was instructed by olympus to select loadlcg/function start on the sub control panel of device and the loadlcg was successful.The user was also instructed to wait until the temperature reached 20 degrees c to test again.The device is operating properly and the acecide test strips are operating properly.No other issues have been reported.If additional information is obtained a supplemental report will be filed.

Event Description

A nurse at a user facility reported that after replacing the acecide-c on an oer-pro, the acecide test strips failed on two devices.The acecide checker indicated that the disinfectant did not pass the mrc test.The issue occurred during reprocessing.There was no patient involvement or injuries.No additional information has been obtained.

Manufacturer Narrative

The investigation has been completed.A device history record (dhr) review was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The instructions for use (ifu) states: ¿checking the disinfectant solution concentration level.The container used in the following check, such as a beaker, and the drain connector should be completely dry.Residual moisture will affect the result.¿ the root cause could not be conclusively determined.Probable causes that could have led to the reported event include that mrc test was not performed correctly for moisture adhered to test strips, or the test strips had some problem.

• 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: 11020316
• MDR Text Key: 221858257
• Report Number: 8010047-2020-10475
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1