MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE LIGATING DEVICE

Model Number	HX-400U-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
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 sedation of an unknown therapeutic procedure the metal of the loops handpiece broke and the poly loop was stuck inside of the patient which require side cutters to remove.There was a delay if approximately 15 minutes and the procedure was completed with a backup device and no reports of patient harm.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields: d8, h2, h3, h4, h6, and h11.The device was not returned to olympus for inspection and the reported failure was not confirmed.The most probable cause of the complaint is categorized as; cause not established, which is the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.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 LIGATING DEVICE
• Common Device Name: SINGLE USE LIGATING DEVICE
• 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: 21909550
• Report Number: 9614641-2025-00596
• Device Sequence Number: 4059289
• Product Code: MND
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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-400U-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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