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 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to replace the damaged lid.The device passed all the service inspections.Software attributes have been verified and confirmed.No other issues were reported.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility reported that a lid was cracked on an oer-pro endoscope reprocessor.No patient involvement or injury was reported.No additional information has been obtained.

Event Description

Additional information was received from the contact at the user facility: the oer-pro was being used while it had the cracked lid.No leak was discovered.There was no patient risk of infection.No concerns were noticed since the cracks were around the hinges.The cracks were also very tiny and hard to see.The contact states that there were no photos taken of the cracked lid since the cracks were very small.The lid was replaced to prevent future problems.The lid could have been used longer, but it was determined to be necessary to change the lid to avoid future concerns.Before using the oer-pro, the condition of the unit is checked as part of the start-up process.No sensors went off.The minimum effective concentration is checked every cycle.The last pm for the oer-pro was (b)(6) 2021 and no problems were noted.The contact stated he was not sure when the last in-service was performed with the staff.The oer-pro is back in service after being repaired.

Manufacturer Narrative

This report is being supplemented to provide additional information provided by the customer.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Probable causes for a cracked lid include: the lid contacting with a scope when it was closed and/or an external impact to the lid with a hard object.Since the device was manufactured over nine years ago, it is possible that aging deterioration may have been a contributory factor to the cracked lid.The device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Design of the device or manufacturing cannot be confirmed as factors to cause the event.Per the instructions for use (ifu): "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." the most probable cause for the reported event is user handling.

• 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: 11340013
• MDR Text Key: 232593014
• Report Number: 8010047-2021-02773
• 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,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• 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: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1