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

Model Number OER-PRO

Device Problem Infusion or Flow Problem (2964)

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

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

An olympus technical support engineer assisted the customer in troubleshooting the device.The olympus representative advised the customer to perform the following steps: disconnect the unit for 30 seconds and reconnect/turn back on to reset.Perform an "air purge" to drain the tub.Perform an "alcohol flush" to toggle the 3 port valve to a different position.Perform a "rinse" function to toggle the 3 port valve to the opposite position.The olympus representative then advised to request a field service engineer if the issue recurred.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the endoscope reprocessor was having a draining issue.The customer further stated the fluid was in the tube.There was no patient involvement or impact to patient care reported for this event.

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 11 years since the subject device was manufactured.Based on the results of the investigation, the cause is likely temporary malfunction of the drain pump.The drain hose tip may have been clogged by incorrect position of the hose or a large amount of drainage from other equipment and/or devices, which made drainage capacity low.This issue is addressed in the instructions for use (ifu): "if the drain hose is placed at incorrect position, user can use the equipment without problem by positioning the hose according to figure 4.2 at ¿4.1 installation conditions - drain hose precautions¿ in ifu (installation manual)." e2, e3 ¿ three attempts were performed to obtain occupation for the reporter but were not successful.If additional information is obtained at a later date, a supplemental report will be submitted.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: 12377179
• MDR Text Key: 268467400
• Report Number: 8010047-2021-10838
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• 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: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1