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

Model Number OER-PRO

Device Problem Fluid/Blood Leak (1250)

Patient Problem Cough (4457)

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.Olympus did help trouble shoot the issue over the phone, and it was discovered that the acecide bottles may have been loaded backwards causing the fluid leak and inability to close the door properly.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported that an endoscope reprocessor experienced error code e51 (leak detected).The end user reported that the acecide door initially could not be closed.Both acecide bottles were removed and the drawer could then be closed.At this point it was noted there was a spill of acecide.The end user reported inhaling acecide fumes resulting in coughing and also getting some acecide on this hands.The end user reported wearing proper personal protection equipment.No additional consequences to the end user have been reported.Additional details regarding the end user/reported event have been requested, at this time, no additional information has been provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to the user closing the disinfectant bottle drawer with the acecide bottles loaded backward which may have caused the leaking within the equipment.Attempts to requests additional information were completed.However, no customer response was received.

• 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: 11921188
• MDR Text Key: 253809244
• Report Number: 8010047-2021-07000
• 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: 08/05/2021

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 07/27/2021
• Supplement Dates FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1