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

Model Number OER-PRO

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

Customer support advised the customer to restart the drain lcg process and the lcg drained without error.The customer was also instructed to select load lcg on the subpanel.The customer was able to open the door and load lcg on the unit.It is thought that the event was possibly a result of user error initially.The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.

Event Description

It was reported the customer was unable to drain the disinfectant bottle drawer (lcg) on the unit and was also unable to a load the lcg when selected.

Manufacturer Narrative

This report is being supplemented to provide additional information (h10) regarding the reported event.Additional information received identified the issue has been resolved.After the unit completed the cycle, the customer was able to load a new set into the unit with no errors.

Manufacturer Narrative

This report is being supplemented to provide additional information (h10) regarding the reported event.Additional information received identified this event was a result of user error.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the investigation results, the user tried to pull out disinfectant bottle drawer to start disinfectant loading, but was unable.When instructed to drain the disinfectant before starting the loading, the user succeeded.Therefore, the suggested event was due to the user handling, not due to the device design.The device's operation manual gives direction under section 7.12 "replacing the disinfectant solution¿.A review of the device history record found no deviations that could have caused or contributed to the reported issue.

• 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: 10373631
• MDR Text Key: 201891911
• Report Number: 8010047-2020-05339
• 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,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1