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

Model Number OER-PRO

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to replace the damaged connector.The equipment was repaired according to specifications.No other issues were reported.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility reported a damaged sensor/scope connector on an endoscope reprocessor.There was no patient involvement or injuries reported.No additional information has been obtained.

Manufacturer Narrative

This report is being submitted to provide the results of the manufacturer's investigation.As part of the investigation, a review of the device history record (dhr) and a review of the instructions for use (ifu) were conducted.The dhr review did not find any abnormalities or anomalies identified during production.The device met specifications upon release.The root cause could not be confirmed.Possible causes include stress caused by the user or impact with a hard object.The ifu contains the following statements that may help prevent or detect the reported issue: "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." 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: 11380934
• MDR Text Key: 234330247
• Report Number: 8010047-2021-03011
• 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: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1