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

Model Number OER-PRO

Device Problem Mechanical Jam (2983)

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

Event Date 03/22/2022

Event Type  malfunction  

Event Description

As reported by the customer for this event, the device was stuck in the load lcg cycle for loading the disinfectant.There is no patient involvement.There was no error code received.Customer had dumped the old acecide (disinfectant) and had pushed the load button before adding the new acecide was fully added to the device.Troubleshooting with the technical assistance center (tac) specialist resolved the issue.This required an error message to be deliberately created and then the machine reset.

Manufacturer Narrative

The device is not available for evaluation; as such, a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct d9.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, the event likely occurred due to the following: - dried residue piled up in the disinfectant bottle guide unit and stopped the disinfectant bottle tray unit from smoothly sliding.- since the disinfectant preparation process was suspended to clean the dried residue, acecide preparation was not done in the correct order.The instructions for use provide the disinfectant preparation method in ¿chapter 7 routine maintenance - setting up the disinfectant solution¿.By following the method, the user can complete the preparation.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: 14112282
• MDR Text Key: 298794917
• Report Number: 8010047-2022-06324
• 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: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/2012
• 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