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 Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

There is no additional information for this event as yet.Supplemental report(s) will be filed as any information becomes available.Olympus field service engineer (fse) was dispatched to the user facility.A device evaluation completed for the device.The user¿s complaint was confirmed.The device was observed to have a broken gray connector from basin, which was replaced.Equipment repaired and verified according to oem instructions.Software attributes verified and confirmed.The covers of the oer-pro were not removed so an electrical safety check was not required.

Event Description

As reported for this event, during a preventive maintenance the device was observed to have a broken gray connector.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 in sections: g4, g7, h2, and h10.The reported issue of the device is a broken gray connector from the basin.The device history record review confirmed that device conformed to specifications at the time of shipping.The subject device has not repaired in the past year.No factor from the design nor structure of the device contributed to the event.The root cause of the event cannot be conclusively determined.It is likely that some impact caused the gray connector to be chipped, or the connector unit was loosened and the unit came apart.The cause of the event would be accumulated stress by loosening or the user hitting the connector to something hard.Connecting tube was seemingly impossible to be connected because of the gray connector breakage.This event is preventable safely by conducting the inspection.The instructions for use includes the following statements: ¿ inspection before use: 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 ¿ warning: do not use the equipment if any connector seems to be damaged or defective.Using the equipment when an irregularity has been detected may interfere with reprocessing.Furthermore, fluid leakage may damage peripheral device or facilities near the equipment.

• 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: 10447868
• MDR Text Key: 212331543
• Report Number: 8010047-2020-05805
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

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: No Information
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1