MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR

Model Number OER-PRO

Device Problem Mechanical Problem (1384)

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

Event Date 04/27/2023

Event Type  malfunction  

Manufacturer Narrative

During troubleshooting with technical assistance center (tac), the customer performed a drain disinfectant lcg and then a load lcg but could not close the door.The customer was recommended to visibly inspect the load tray and within, to see if there were any blockages.An olympus field service engineer (fse) was dispatched to evaluate and repair the device.The fse manually pulled back the lock and closed the drawer, then did a program b then a drain lcg followed by a load lcg, and everything worked normally.The device was repaired and verified according to original equipment manufacturer (oem) instructions, software attributes were verified and confirmed.Device investigation was completed with the information available.Based on the results of the investigation, the reported issue was likely due to incorrect detection by the sensor even though the disinfectant bottle was not installed.As for the cause of the detection, temporary contact failure of contacts inside the sensor may have occurred.The root cause could not be identified.A review of the dhr found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus technical assistance center (tac), during reprocessing, the disinfectant drawer of the endoscope reprocessor could not be closed.There was no harm or user injury reported due to the event.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16993365
• MDR Text Key: 316290700
• Report Number: 9610595-2023-07944
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2023

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: 04/27/2023
• Initial Date FDA Received: 05/24/2023
• Date Device Manufactured: 01/27/2016
• 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