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

Model Number OER-PRO

Device Problems Defective Component (2292); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The field service engineer onsite repaired the device by replacing the grey connectors.Once completed, the device was tested and passed all required testing and specifications.

Event Description

It was reported that the grey air/water/instrument channel connector on the oer-pro was found broken and the valve was missing.There were no other details provided regarding the event.There was no patient involvement on this report.

Manufacturer Narrative

The device history records for this device were reviewed 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 cause of the event cannot be conclusively determined.Probable cause could be due to some impact that caused damage (chipped) to the grey connector, or the connector unit was loose and the unit came apart.Possible causes include stress to the device unit during cleaning.Design of the device or manufacturing, cannot be confirmed as factors to cause of the event.Ifu(instructions for use) states: check the following for each connector.The connector should be fixed firmly.The o-rings should be free of abnormalities such as cracks, tears, or dents.Do not use the equipment in any connector seems to be damaged or defective.Using the equipment when an irregularity has been detected may interfere with reprocessing.Furthermore, fluid leakage may damage peripheral devices or facilities near the equipment.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: 10323380
• MDR Text Key: 223253133
• Report Number: 8010047-2020-04786
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1