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

Model Number OER-PRO

Device Problem Restricted Flow rate (1248)

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

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, a field service engineer (fse) was dispatched to the customer¿s site.The fse checked the oer-pro for noise and low flow while the basin was filling.There were no malfunctions or errors noted with the oer-pro.The fse reported that the issue was with the facility¿s water hammering which is external to the equipment.The fse reported that the facility¿s maintenance will check the incoming water supply and regulators.An investigation is ongoing to obtain additional information regarding the reported event.

Event Description

The customer reported that the oer pro had incoming water noise and lower than normal flow when the tub was filling.There was no patient involvement.

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.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation and additional information received from the customer, the water pressure was lower due to an issue of water supply at the user facility.Olympus will continue to monitor the field performance of 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: 12225439
• MDR Text Key: 263461270
• Report Number: 8010047-2021-09355
• 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: 09/22/2021

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: Health Professional
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/26/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1