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

Model Number OER-PRO

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

No details of the event are known at this time.Supplemental report(s) will be filed as the information becomes available.The device has been returned and a device evaluation completed for it.The user¿s complaint was confirmed.A field service engineer (fse) evaluated the device.There was an issue with the connector for the connecting tubes in the basin.The connector was replaced.Fse verified that the device was functional in all respects.No other issues were found.The covers of the device were not removed so an electrical safety check was not required.In conclusion, the cause for the issue could not be established.

Event Description

As reported for this event, during reprocessing, the device had a pin missing in the middle of the gray connection in the tub.There is no patient involvement.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Please see the updates.The device history review confirmed that device was shipped according to specifications.The root cause of the issue of the missing pin in the middle of the gray connection in the tub cannot be conclusively determined.It became loose and then was missing.Accumulated stress could loosen the pin.There was no factor of the design or structure of the device that could contribute to the issue.Instructions for use (ifu) includes statements: in case gray connector is loosen, abnormality is detectable by conducting the following inspection before use and by 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10097213
• MDR Text Key: 223257630
• Report Number: 8010047-2020-02949
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• 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