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

Model Number OER-PRO

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to investigate the issue.When the fse arrived on site it was observed that the det icon was flashing.The fse troubleshooted the device and confirmed that the unit was correctly aspirated using the detergent discharge nozzle.Even after correctly aspirating the unit, it was still producing an e95 error.The uptake nozzle of the endoquick detergent was inspected and the fse advised the customer to replace it.The fse replaced the uptake nozzle and a cycle was ran successfully with no errors.During the test cycle, the fse noticed that the water booster pump was defective and not functioning properly.The department was informed of the issue to be corrected.No other issues were found during the on-site inspection.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility reported an e95 error on an endoscope reprocessor oer-pro.There was no patient involvement or injuries reported.No additional information has been obtained.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on legal manufacturer's investigation.As stated in the initial report, a field service engineer (fse) was at onsite at the user facility for investigation.After initial troubleshooting, it was determined that the unit is in proper, working condition.However, the fse had noticed that during the test cycle, that the water booster pump (provided by facility) was faulty and not functioning properly.Customer had informed their facilities department who observed the issue.Customer's facility department to correct non-working water booster pump.Customer's incoming water was hitting the first pre-filter @ 20 psi and exiting the pre-filtration system @ around 10 psi.The test cycle completed successfully, but advised customer that the incoming water pressure is below the specs of the machine.The device inspection result confirms it was not a device defect.The suggested event is the environment at the user facility.No adverse event occurred.Investigation also identifies: - the subject device had no repair history in the past year.- abnormal use of the device was not reported.- no similar complaint was confirmed from the user on the same defect, the same cause, and the same product - no similar complaint was confirmed from other facilities on the same defect, the same cause, and the same product - since the suggested event was on environment at the user facility, reproduction of the event was not conducted - dhr review confirms the subject device was shipped in accordance with specifications - confirmed "water supply conditions, chapter 4 installation of equipment" in ifu states about the suggested event.- dmr review determined case is not due to device design.Cause: according to the report, water pressure at the user facility was only 10psi(about 0.07mpa).The cause of the event was seemingly the water pressure at the user facility, which was being lower than oer-pro required.At least 0.1mpa is required to work the device in accordance with the specifications.Therefore, we could not confirm any factor to cause the event from design nor structure of the 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10793549
• MDR Text Key: 225941768
• Report Number: 8010047-2020-08578
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

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: Health Professional
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 01/05/2021
• 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