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

Model Number OER-PRO

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

During troubleshoot, the technical support engineer informed the customer to point the end of the hose away from the lid gasket and that an olympus field service engineer (fse) will be dispatched to the facility to inspect the referenced aer machine.The olympus fse visited the user facility and confirmed the customer reported leak.The yellow connector had a small piece broken/missing on it and the aer is experiencing an intermittent e05 error code.The fse replaced the yellow connector.The investigation is ongoing.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.

Event Description

The olympus technical support engineer was informed that the customer automatic endoscope reprocessor (aer) machine has a leaking issue, ¿the lid is leaking¿.The customer reported problem was found during collection of water samples.The yellow connector is broken and the open end of hose was pointing towards the lid seal and water pressure exiting the tubing was causing the lid seal to lift up and leak.The reprocessing staff holds the lid down, so it does not leak.No death, injury or harm was reported.

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.The cause of the reported event cannot be conclusively determined.Based on the results of the investigation, it is likely the connector could not be connected as some impact was added to the connector and the connector became loose and came apart.Probable causes for the event include: "accumulated stress over time which caused the connector to get loose.Unintentional impact to the connector with something hard." per the instructions for use: ¿check the following for each connector.The connector should be fixed firmly.The o-rings should be free of abnormalities such as cracks, tears, or dents.¿ and ¿warning -do not use the equipment if any connector seems to be damaged or defective.Using the equipment when an irregularity has been detected may interfere with reprocessing.Furthermore, fluid leakage may damage peripheral device or facilities near the equipment.¿ olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report was submitted to provide additional information regarding the fse¿s service event at the user facility.The broken yellow connector was replaced, customer was collecting water sample with the open end clear tubing end of the hose pointing toward the lid seal., water pressure exiting the hose was causing the lid seal to lift up causing water leakage.Customer was in-serviced to point the end of the hose away from the lid gasket.Equipment was repaired and verified according to oem.Software attributes have been verified and confirmed.

Manufacturer Narrative

This supplemental report was submitted to provide a correction to the aware date on the previous supplemental report regarding details from the fse.The correct aware date is march 24, 2023 instead of february 24, 2023.

• 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15670740
• MDR Text Key: 306785424
• Report Number: 9610595-2022-03321
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2015
• 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