MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. WATER FILTER

Model Number MAJ-2317

Device Problem Restricted Flow rate (1248)

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

Event Date 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to an olympus service center for evaluation.The evaluation is still in progress.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.

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, 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 subject device (maj-2317-water filter).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 water filter (maj-2317), with patient identifier (b)(6).The issue with the olympus endoscope reprocessor (oer-6) is being reported on the medwatch with patient identifier (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to the adhered substances temporarily increased in the filter and extended the programming process time.It is also, likely the water supply time was longer than usual since the amount of water supplied was not sufficient and a decreased the specified amount.Additionally, it is possible the iron oxide, aluminum derived from the piping used in the surrounding area and; the silicon, calcium, phosphorus mineral components, chemicals, and components are present in supplied tap water.Olympus will continue to monitor field performance for this device.

• Brand Name: WATER FILTER
• Type of Device: WATER FILTER
• 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: 14211930
• MDR Text Key: 299162933
• Report Number: 8010047-2022-07060
• 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: 08/11/2022

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: MAJ-2317
• Device Lot Number: 1X01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• 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: 07/14/2022
• Supplement Dates FDA Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2022
• 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: OER-6 OLYMPUS ENDOSCOPE REPROCESSOR