MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE RELOADABLE CLIP APPLICATOR

Model Number	HX-810UR
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during clip placement; the sheath comes off and the clip itself is not released.The event was repeated both the day before and on friday out of 5 total clip-layers.The issue occurred during an unspecified procedure.There was no report of patient harm.Report 1 of 5.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This report is being submitted to provide the results of the final investigation and correction to previously reported event.Corrected fields: d4 (model number, lot number udi) the device was returned to olympus for inspection, and the reported failure was confirmed.The investigation determined the following: due to some influence during clipping, the amount of operating force increased.An excessive tensile load was applied to the operating wire due to the increased operating force.The operation wire came out from the caulking part due to the load exceeding the resistance.Clip could not be detached from the applicator.Based on the results of the investigation, a root cause could not be identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE RELOADABLE CLIP APPLICATOR
• Common Device Name: CLIP APPLICATOR
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22298551
• Report Number: 9614641-2025-01028
• Device Sequence Number: 12971108
• Product Code: PKL
• UDI-Device Identifier: 04953170421341
• UDI-Public: 04953170421341
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K240617
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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 Expiration Date: 10/31/2025
• Device Model Number: HX-810UR
• Device Lot Number: 2YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown