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)
Type of Reportable Event	Malfunction
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
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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the final investigation.Additional information added to the following fields: h2, h6.Corrected fields: d9.The device was not returned to olympus for inspection, only the open original sterilization pack was returned.Based on the results of the investigation, a root cause could not be determined as the actual device was not returned for evaluation.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from the customer.

• 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: 23073681
• Report Number: 9614641-2025-01563
• Device Sequence Number: 4748789
• Product Code: PKL
• UDI-Device Identifier: 04953170390739
• UDI-Public: 04953170390739
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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 Model Number: HX-810UR
• Device Lot Number: 2YK
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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