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

Model Number OER-PRO

Device Problem Filtration Problem (2941)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer visit was required as the customer changed the filters to the machine to resolve the issue.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported they wanted to change the filters in their automated endoscope reprocessor as the flow of the water in the reprocessing basin has become weaker than before.No patient injury, harm or infection was reported.

Event Description

On march 10, 2021, the customer requested an olympus field service representative to come to the user facility change the water filters on two automated endoscope reprocessor (aer) machines as the customer informed the filters were due to be replaced.There was no reported allegation of a malfunction associated with the device and there was no patient injury or infection reported.This report is for 2 of 2 aer machines.

Manufacturer Narrative

On april 6, 2021, an olympus field service engineer noted the customer changed the water filters themselves as the flow of the water in the reprocessing basin was weaker than before due to clogging.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the original equipment manufacturer (omsc) and to update the following sections: g3, g6, h2, h4, h6 and h10.Omsc performed the device history records for this device 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 investigation was completed by omsc and determined that there is no manufacturing, material or processing related cause for this failure mode.The cause of the reported event was due to the user; user did not replace the filter in specified time period.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: replacing the water filter (maj-824) replace the water filter at least once a month to prevent contamination of the rinse water.The water filter should also be replaced whenever an error code indicating water supply insufficiency [e01] is displayed.The water filter should be replaced by following the flow shown below.Omsc 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: 11638689
• MDR Text Key: 269068368
• Report Number: 8010047-2021-04732
• 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,Followup
• Report Date: 06/10/2021

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: Other
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 04/06/2021; 06/08/2021
• Supplement Dates FDA Received: 04/21/2021; 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1