MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. LONG CLIP

Model Number	HX-610-090L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unspecified procedure, the clip was removed from the sheath for use on a lesion inside the patient¿s body, but it detached immediately and became unusable.The detached clip was retrieved from the patient¿s body and disposed of by the hospital.There were no further reports of patient harm.
Additional Manufacturer Narrative
The device was not returned to olympus for inspection.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.It is likely that the reported issue occurred due to the following mechanism: the clip dislodgement occurred due to the hook of the rotational clip device being extended too far and coming into contact with tissue inside the body.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: LONG CLIP
• Common Device Name: LONG CLIP
• 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: 23089685
• Report Number: 9614641-2025-01574
• Device Sequence Number: 10502194
• Product Code: PKL
• UDI-Device Identifier: 04953170415159
• UDI-Public: 04953170415159
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K240617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HX-610-090L
• Device Lot Number: 49K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown