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

Model Number OER-PRO

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

The olympus field service engineer (fse) was dispatched to the user facility.Fse inspected the error log and no related errors were found.Checked internal tubing and all appear to be intact and connected properly.Ran several performance test cycles, did not observe any black debris in basin following the test cycles.Drained fluid in disinfectant tank and inspected the tank internally, found small chunks of debris stuck to the wall of the tank.There's a possibility that the debris was getting picked up during the circulation of the chemical and ends up in the mesh filter.Wiped down the inside of the tank thoroughly, ran multiple performance test cycles, no black debris found in disinfectant tank and in the basin mesh filter.Equipment repaired and verified according to oem instructions.Software attributes have been verified and confirmed.Equipment passed the electrical safety test.The cause could not be determined.No further information was reported.

Event Description

The customer reported to olympus that the device had black debris periodically found in the mesh filter.There was no patient injury reported.

Manufacturer Narrative

Upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 10413131
• MDR Text Key: 203104936
• Report Number: 8010047-2020-05508
• 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: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• 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: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1