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

Model Number OER-PRO

Device Problem Residue After Decontamination (2325)

Patient Problem No Patient Involvement (2645)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation and a definitive root cause could not be determined.The user facility reported that the device was operating properly after changing the detergent.

Event Description

The user facility reported to olympus that foaming during detergent cycle was observed.There was no patient involvement and no injury reported to olympus.

Manufacturer Narrative

Please see updated sections: g4, g7, h2, h3, h6 and h10.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.Based on investigation results, it was confirmed the device worked normally after changing detergent therefore, the user may have used detergent other than olympus recommended or quality of tap water may have changed temporally, which made the detergent more foamy than usual.Ifu(instructions for use) states: always use an olympus-validated detergent.Otherwise, the endoscope may not be properly cleaned and as a result, the endoscope may not achieve high-level disinfection.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: 9929717
• MDR Text Key: 222559742
• Report Number: 8010047-2020-02008
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• 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: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1