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

Model Number OER-PRO

Device Problem Filtration Problem (2941)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

Through troubleshooting with the assistance of olympus technical support via the phone, the customer determined that the recirculation screen was the likely cause of the e14 errors and a new screen was ordered.In addition, the customer requested an evaluation of the device by a field service engineer (fse).A fse was dispatched for an onsite visit and an evaluation of the oer-pro was performed.The fse reviewed the error log and noted multiple errors.The fse observed a low level of fluid in the tank and the tank sensor array was turned 90 degrees from the normal setting; scale buildup was observed on the circulation port mesh filter.The fse replaced the mesh filter and cap, tank sensor array and switching valve; significant wear was noted on drain valve side upon removal of the switching valve.The fse verified performance of the device following the service.Based on the results of the fse's evaluation, the likely cause of the reported problem is insufficient maintenance and not following the device instructions for use (ifu).The ifu directs the user to clean the mesh filters at the end of every working day.In addition, "prior to reprocessing," the end user is directed to "check the disinfectant concentration using the test strip every time you use the reprocessor." the device ifu provides the following instructions and warning statements: warning: "take care not to damage the fluid level sensor when cleaning it.If the sensor is damaged, it may not be able to correctly detect the fluid level and the endoscope reprocessing may be insufficient." "to ensure safe, reliable operation, inspect and clean all parts of the device regularly." warning: "a clogged mesh filter not only prevents the equipment from functioning properly, but may also result in ineffective reprocessing.".

Event Description

A user facility reported to olympus that their oer-pro device generated e14 errors and that the efficacy of the high-level disinfectant was not checked after every cycle.There was no patient involvement and no harm or injury associated with the reported problem reported to olympus by the user facility.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Please see the updates in sections: g4, g7, h2 and h10.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm confirmed the subject device has not been repaired in the past year.The lm determined that the cause of the reported event ¿e14¿ error message was due to the method of confirming the efficacy of the disinfectant, not a device abnormality.The lm reported that it is possible to confirm the concentration level of the disinfectant correctly by conducting the inspection as states in chapter 3 ¿ inspection before use 3.10 ¿checking the disinfectant solution concentration level.¿prior to reprocessing, check the concentration of the disinfectant solution using a test strip to verify that the concentration of disinfectant solution meets the minimum recommended concentration.Replace the disinfectant solution when it fails to meet minimum recommended concentration or beyond the specified use life.¿.

• 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
• MDR Report Key: 9957565
• MDR Text Key: 192735987
• Report Number: 8010047-2020-02197
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1