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 02/01/2023

Event Type  malfunction  

Event Description

The customer reported to olympus technical assistance center (tac), during reprocessing, the endoscope reprocessor exhibited error e51 indicating water leakage occurred and the lcg drawer could not be locked (was flopping).There was no harm or user injury reported due to the event.

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to evaluate and repair the device.The fse inspected the device, the drawer solenoid was noted to be burnt and the locking mechanism was damaged.There was no visible fluid and e-51 did not occur during the inspection, but the washer had a strong odor of acecide.Fse ordered the bottle guide assembly.Fse cleaned up the cassette tray area and disinfectant drip tray, then replaced the cassette tray assembly and cutters.Fse also aligned bottle switches and confirmed the latch mechanism was operating, verified operation, repaired, and verified the device according to original equipment manufacturer (oem) instructions and software attributes were verified and confirmed.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

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, the definitive root cause of the disinfectant bottle unable to be installed could not be determined.It was unknown how the disinfectant lock unit was damaged.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿to avoid malfunction, do not attempt to pull out the disinfectant bottle drawer while it is locked.¿ olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16468451
• MDR Text Key: 310958839
• Report Number: 9610595-2023-03594
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

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: 02/01/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2016
• 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