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

Model Number OER-PRO

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to check the machine for proper functionality.While onsite, the fse was informed of the disinfectant (alcohol) lightening to a very light pink.The fse checked the disinfectant lots and compared it to a second machine which was not having issues.The disinfectant was passing efficacy tests up to 24 cycles but had lost all pink coloring at the 24th cycle.The fse checked the disinfectant level in the tank and it was equal to the second machine.No other issues were reported.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility reported that the alcohol (the disinfectant) was loosing color during the 5th reprocessing cycle while using an endoscope reprocessor.No patient involvement or injuries were 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.A review of the device history record confirms the subject device was shipped in accordance to specifications.Based on the results of the investigation, the solution likely looked discolored for it was foamed while draining to the disinfectant tank.In addition, repair history records confirm the subject device had no repairs within the last year.A review of the maintenance and inspection sections of the instructions for use confirms information is identified related to the phenomenon: 3.10: checking the disinfectant solution concentration level.5.2: cleaning the mesh filters.

• 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: 11008049
• MDR Text Key: 227270584
• Report Number: 8010047-2020-10335
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• 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: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1