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

Model Number OER-3

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.Establishment name: (b)(6) hospital.

Event Description

An olympus employee reported on behalf of a customer, while cleaning up after using an endoscope reprocessor, when attempting to remove the cleaning tube connected to the cleaning tank, the connector to the forceps port separated.The cleaning tube did not come off while the washer was running.The cleaning tube has never come off during cleaning.The cleaning tube was inspected every time it was used and there were no problems.The subject device has been used without any problems with the tank side connector.The customer stated when removing the cleaning tube, force was applied that caused it to rotate.There was no report of patient harm associated with this event.

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, a definitive root cause of the reported brocken/separated connector on the cleaning tank side issue could not be determined, as the device was not returned to olympus for evaluation and no additional event information was reported or available, however, it is possible that the connector was stressed while rotating to loosen, causing the part to break the event can be detected/prevented by following the instructions for use which states: oer-3 chapter 3 inspection before use section 3.2 inspecting the equipment¿s connectors check the following for each connector.- the connector should be connected firmly.- the o-rings should be free of irregularities such as cracks, tears, or dents.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 devices or facilities near the equipment.Caution connect each connector firmly by pushing until the connector clicks into place.After connection, pull the connector gently to confirm that it cannot be disconnected easily.Olympus will continue to monitor field performance for this device.

• Brand Name: OLYMPUS 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: 18103216
• MDR Text Key: 328499857
• Report Number: 9610595-2023-16821
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

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-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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