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

Model Number OER-PRO

Device Problem Filling Problem (1233)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

Upon evaluation of the device, after removing the covers of the device, the field service engineer (fse) found that when the drain lcg function was carried out, and the dump process of disinfectant was completed by the device, it was filling again once the tub began to fill with rinse water.Fse identified that the dilution valve not functioning as it should was causing this issue and needed to be replaced.After replacing the dilution valve and running tests the fse found no further issues with the device.Fse completed test cycles as well with no issues.Fse helped with detergent and alcohol replenishments.Equipment repaired tested and verified to original equipment manufacturer specifications by the fse.Software attributes were verified and confirmed.Equipment passed the electrical safety test.The device was fully functional.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

Field service engineer (fse) went on site for the customer reported issue of the loading the lcg (disinfectant) process.Upon discussing with the customer, the fse found that when the drain lcg function was carried out, the water was collecting in the disinfectant reservoir.This was preventing the load lcg function to be executed.There is no patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the event occurred because water that dilutes the disinfectant was not properly supplied, or the specified amount of disinfectant was not filled up due to failure of dilution valve.However, we couldn¿t conclusively specify the cause of the event.This event can be prevented by following the instructions for use which state: "when using olympus-validated ready-to-use disinfectant solution and add the disinfectant solution carefully.The max line and min line of the disinfectant solution indicator are the reference line that indicates too much disinfectant solution or insufficient amount of disinfectant solution in the tank." olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13193484
• MDR Text Key: 283425086
• Report Number: 8010047-2022-01067
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 02/14/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1