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

Model Number OER-PRO

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, on november 16, 2020 an olympus field service engineer (fse) was dispatched to the customer¿s site to service the aer.The fse reported that the lid was cracked in the left rear corner and was replaced.The lid was removed per the oer-pro technical guide and confirmed the procedure by using the attached checklist.The fse replaced the alcohol connector that was broken when the alcohol was added.Also, the oer¿s drain hose was replaced as it was leaking due to the customer moving the oer-pro to clean.The software attributes were verified and confirmed.The covers of the oer-pro were not removed so an electrical safety check was not required.The fse reported that the cause of the cracked lid is unknown.The oer-pro instruction manual provides the following statements to prevent damage to the oer-pro.Before using the equipment, always check that there is no irregularity regarding the following points on the lid and the lid packing.If there is any irregularity, cleaning fluid or disinfectant solution may leak out.The lid is not cracked, broken, or otherwise damaged.When closing the lid, be careful not to get the connecting tube caught between the reprocessing basin and lid and make sure the endoscopes and the washing case are not touching the lid.Close the lid after ensuring that the cover of the washing case is closed.If the endoscopes and the washing case are touching the lid, adjust their positions and close the lid.If the lid is closed while contacting the endoscopes or accessories such as the washing case and the connecting tubes, the endoscopes, the accessories and the equipment may get damaged or water leakage may result.

Event Description

The service center was informed that the lid to the user facility¿s oer-pro automatic endoscope reprocessor (aer) was cracked.No fumes or smoke were reported.There was no positive device cultures.There was no patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information and device evaluation results.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer confirmed the subject device was shipped in accordance with specifications via dhr.The legal manufacturer reported that the root cause could not be determined.The lm reported that the most probable causes for the reported event are as follows: similar event was confirmed from other user facilities.Possible causes are the lid being contacted with a scope when it was closed and/or something hard hit the lid.Design of the device or manufacturing cannot be confirmed as factors to cause of the event.Though we presume the event was due to the user handling, it is difficult to specify.

• 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: 10971104
• MDR Text Key: 227201935
• Report Number: 8010047-2020-10047
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 12/21/2020
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1