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 Type  malfunction  

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.

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)(4).

Manufacturer Narrative

The exact serial number and manufacturing date of the subject device is unknown.The facility has two oer-6's serial number (b)(6).Both device history records (dhr) were reviewed.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the dhrs found no deviations that could have caused or contributed to the reported issue.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: 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: 13946475
• MDR Text Key: 288200160
• Report Number: 8010047-2022-05291
• 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: 08/17/2022

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: 02/28/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 07/25/2022
• Supplement Dates FDA Received: 08/17/2022
• 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: MAJ-2317.WATER FILTER.