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

Model Number OER-PRO

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Patient Involvement (2645)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated in the field.The fse identified the customer had two sets of connecting tubes connected with only one scope being processed in the basin.The customer is to schedule an additional in-service with the endoscopy support specialist (ess) and fse.The cause of the reported event cannot be determined at this time.If additional information becomes available at a later time, this report will be supplemented.

Event Description

It was reported that during a product maintenance call, the field safety engineer (fse) identified the reprocessor was being improperly used.As a result, the fse advised it was possible the scopes were not being reprocessed properly.Per the customer, the scopes have been reprocessed this way for some time.The customer is determining the next course of action as it pertains to patient notification.Additional information is unavailable at this time.

Manufacturer Narrative

This report is being supplemented to provide additional information and corrected data regarding the reported event.After further review of the record it was identified that in addition to the additional in-service request, it was reported the customer was trained on how to connect the tubes properly.Additionally, the connection tube installation portion of instruction manual was reviewed with the customer.

Manufacturer Narrative

The investigation has been completed.A device history record (dhr) review was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The instructions for use (ifu) states: ¿disconnect the connecting tubes from the connectors on the equipment whenever the tubes are not used for reprocessing.If reprocessing is performed while the unnecessary tubes are connected, the effectiveness of cleaning/disinfectant may be reduced.¿.The root cause could not be conclusively determined.Probable causes that could have led to the reported event include due to the user handling.That the user conducted reprocessing with connecting the unnecessary connecting tube.

• 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: 10447941
• MDR Text Key: 223646451
• Report Number: 8010047-2020-05806
• 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: 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 the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 07/30/2020; 12/17/2020
• Supplement Dates FDA Received: 08/26/2020; 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1