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

Model Number OER-PRO

Device Problem Filtration Problem (2941)

Patient Problem No Patient Involvement (2645)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to verify and replace the damaged air filter housing.The device was repaired according to specifications.Software attributes have been verified and confirmed.The device passed all the inspections.No other issues were reported.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility reported that the air filter housing was sticking on an endoscope reprocessor.No patient involvement was reported.No additional information has been obtained.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer final investigation.The following sections were updated, g4, g7, h2, h6 and h10.As stated previously the reported event was confirmed by the dispatched field service engineer.In addition, an investigation was performed by the legal manufacturer based off of the information provided.1.A review of similar complaints both at the specific facility and in general was performed with only a limited number of similar complaints.This will be trended.2.A review of the ifu was performed and it was confirmed the ifu gives instruction to inspect the air filter.3.A review of the dhr was performed and there were no issues found within the record associated to the reported event.4.A review of service records and repair records was performed.No repair information for the past year for the product was observed.Conclusion: a root cause could not be definitively identified.It is probable that the air filter could not be removed due to an abnormality in the sleeves that connects the oer-pro and the air filter.As for the cause of the abnormality in the sleeves, it is possible that the sleeves were damaged due to accumulated stress being applied to the sleeves.

• 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: 10711165
• MDR Text Key: 219551019
• Report Number: 8010047-2020-07951
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

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: Health Professional
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1