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

Model Number OER-PRO

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The ess conducted the site visit as requested.The ess performed the water line disinfection and changed the device filters.There were no other issues reported.To date , no patient infection or harm reported.

Event Description

It was reported that the user has been using the machine for about a week and did not prepare the unit for long term storage of approximately 6 weeks.The user stated that there were no error codes on the oer-pro.The reporter stated that the user did not know that they need do anything prior to using the machine.The user conveyed to the olympus endoscopy support specialist (ess) that they are not comfortable doing the line disinfection and requested an onsite visit for the disinfection.There was no patient involvement on this report.No known infection reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the review of the device history records (dhr).The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the reported issue was not identified.It is difficult to reproduce preparation for long time storage.However, it was confirmed that the user stored the device for six weeks without preparing for long time storage of the device.Design of the device or manufacturing, cannot be confirmed as factors to cause of the event.Olympus will continue to monitor complaints for 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10508102
• MDR Text Key: 224632715
• Report Number: 8010047-2020-06343
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2019
• 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