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 Type  malfunction  

Event Description

The customer reported 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 a weaker water flow in the reprocessing basin.An error code was not displayed and the problem was resolved when the water filter (maj-2317) was replaced.The water filter had been replaced previously, about 1.5 months ago, which was earlier than usual.The customer sent the water filter in for evaluation to analyze substances that may be clogging the filter.There were no reports of patient harm associated with this event.Patient identifiers: (b)(6) (maj-2317 water filter) and (b)(6) (oer-6 olympus endoscope reprocessor).

Manufacturer Narrative

The filter has been sent to olympus and the evaluation is in process.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is obtained.

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 since the serial number was not provided.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: 13946005
• MDR Text Key: 288179087
• Report Number: 8010047-2022-05289
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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.