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

Model Number OER-6

Device Problem Restricted Flow rate (1248)

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

Event Date 03/16/2022

Event Type  malfunction  

Event Description

The customer reported that during reprocessing, there was a problem with the water supply time for the washing tank of the oer-6 (subject device), as the time was longer than expected, indicating there was a weaker water flow in the reprocessing basin.The issue was resolved by replacing the water filter (maj-2317).The water filter was previously replaced in february 2022.There was no patient or user injury reported due to the event.This report is being submitted for the issue with the olympus endoscope reprocessor (oer-6), with patient identifier (b)(6).The issue with the water filter (maj-2317) is being reported on the medwatch with patient identifier (b)(6).

Manufacturer Narrative

The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.Device not returned.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿although the reprocessor incorporates a water filter, it may still fail or the water filter shelf life may be reduced if the water contains a large amount of debris and sediment.Replace the water filter (at least once every 2 months.) to prevent contamination of the rinse water, replace the water filter regularly at least once every two months.Also, if the error code [e01] is displayed due to insufficient water supply, replace it.¿ olympus will continue to monitor field performance for this device.

• Brand Name: OLYMPUS 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14212314
• MDR Text Key: 298956345
• Report Number: 8010047-2022-07061
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

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-6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 07/25/2022
• Supplement Dates FDA Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OLYMPUS MAJ-2317 WATER FILTER