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

Model Number	OER-MINI
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the endoscope reprocessor was constantly filling up with water while out of operation and powered off.There were no reports of patient harm.
Additional Manufacturer Narrative
Updated h3 and h4 this report is being supplemented to provide additional information based on the approved final investigation.Based on the results of the investigation, as the device was not returned, the reported malfunction could not be reproduced.The likely cause could be that the water accumulated in the reprocessing basin due to leakage from the water supply valve.The possible causes of the leakage are as follows: the water supply hose was loosely attached due to the breakage of the water supply valve.However, a definitive root cause could not be determined.The event can be detected and prevented in accordance with the following instructions for use (ifu).[installation manual] chapter 5: installation of equipment 5.2 connection of the water supply hose.11.Open the water faucet slowly while checking to make sure that water does not leak from the hose connection areas (around the water supply plug, the faucet side plug, the equipment side plug, and the connection ring).If water leaks, close the water faucet and reconnect the water supply hose 1 and the water supply hose 2.[operation manual] chapter 8: troubleshooting and repair.If any irregularity is detected during an inspection or if the device is clearly malfunctioning, do not use it.Contact olympus for repair.Some problems that appear to be malfunctions may be correctable by referring to section 8.1, ¿troubleshooting guide,¿ on page 213.If the problem cannot be resolved by the described remedial action, do not use the device and contact olympus.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor the field performance of this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• Common Device Name: 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: 20564187
• Report Number: 9610595-2024-22261
• Device Sequence Number: 7460117
• Product Code: FEB
• UDI-Device Identifier: 04953170331619
• UDI-Public: 04953170331619
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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
• Operator of Device: Health Professional
• Device Model Number: OER-MINI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown