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

Model Number OER-PRO

Device Problem Crack (1135)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to replace the damaged lid.The device was repaired following specifications.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.

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, an external impact to the lid and/or a chemical crack due to adhered chemical solution which was not removed.The design of the device and the manufacturing process cannot be confirmed as factors to cause the event.The most probable cause for the reported event is user handling.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.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.

Manufacturer Narrative

This supplemental report is being submitted to provide further information from the manufacturer's investigation.Upon additional investigation, it was found the root cause of the cracked lid was the user closing the lid on the tube.The users were retrained by an olympus field service engineer.Olympus will continue to monitor the field performance of this 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
• MDR Report Key: 11337271
• MDR Text Key: 232801601
• Report Number: 8010047-2021-02750
• 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: 04/27/2021

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: 01/20/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 03/18/2021; 04/08/2021
• Supplement Dates FDA Received: 03/19/2021; 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1