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

Model Number OER-PRO

Device Problem Residue After Decontamination (2325)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the liquid did not contain any particles and that the mesh filter was clean of debris.An olympus field service engineer (fse) was dispatched to the user facility.The fse confirmed the reported issue and replaced the necessary parts.The equipment was repaired and verified according to specifications.The device passed the electrical safety test.If additional information is obtained, a supplemental report will be filed.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

A user facility reported that an endoscope reprocessor contained a black liquid while reprocessing.There was no patient involvement or injuries reported.No additional information has been obtained.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and to correct information provided on the initial report.A review of the device history record confirms the subject device was shipped to specifications.The aware date initially identified within the initial report should have been 09dec2020.Based on the results of the investigation, the phenomenon likely occurred since reprocessing was performed with grease adhering to the inside of the reprocessing basin, the grease was mixed with the disinfectant and appeared black.In addition, it is also likely the inner surface of the hose peeled off due to deterioration, and when the disinfectant was pumped up, it came out as a foreign substance.

• 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: 11194826
• MDR Text Key: 227584392
• Report Number: 8010047-2021-01605
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1