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

Model Number OER-PRO

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to confirm the reported issue.The fse replaced the broken grey connector.The device was repaired to specifications.The device passed all the functional tests.Software attributes were 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 grey connector on the oer-pro was broken, they did not run any cycles after they noticed the grey connector broke.No patient involvement or injuries were reported.No additional information has been obtained.

Manufacturer Narrative

There is more information for the device.This supplemental report is being submitted to provide this information.The device history record review confirmed that device was shipped in accordance with specifications.The device has no repair history within the past year.The device connecter got loose and was broken; this led to the connecting tube not being able to connect.The cause of the loosened connecter is probably that the user applied stress toward loosen direction of the connecter and the stress was accumulated and/or the user hit the connecter to something hard.The instructions for use includes the following statements: the abnormality of the device can be detected by conducting inspection as follows.Chapter 3.Inspection before use 3.3 inspecting the connectors check the following for each connector.The connector should be fixed firmly the o-rings should be free of abnormalities such as cracks, tears, or dents.

• 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: 11340051
• MDR Text Key: 232593260
• Report Number: 8010047-2021-02774
• 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
• Report Date: 04/15/2021

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 Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1