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)
Date of Event	02/21/2025
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 that during a procedure the device handle part broke, the spring flew off and the device got stuck inside the patient.They had to cut the wire with side cutters and took the endoscope out with the device sheath.There were difficulties to cut the device out the patient and they used another device that didn't work.They eventually used a hot snare to cut the device out the patient successfully.There was no harm reported.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation and additional information in fields: b1, d4, h4 & h6 the device was returned to olympus for inspection and the reported failure was confirmed.A root cause could not be identified.Based on the investigation result, a likely mechanism causing the reported event might be one of the following: 1) the loop was placed around the body tissue.2) the tube sheath was pushed forward, and the tissue was temporarily ligated with the distal end of the tube sheath.3) the slider was pulled to tighten the loop.4) because the distal end of the coil sheath was not extended from the tube sheath when the slider was pushed, the loop disengaged from the hook inside the tube sheath.5) the hook protruded from the distal end of the coil sheath, causing the loop to move toward the handle side and enter the coil sheath.6) pulling the hook caused both the hook and the loop to be drawn into the coil sheath together.As a result, the loop became trapped between the hook and the inner surface of the coil, preventing it from moving.7) the slider was forcefully operated in state of ¿6¿ description causing the operation pipe of the slider to deform and break. 1) the sheath was bent near the handle.2) the operating wire could not move because sliding resistance between the sheath and the operating wire increased.3) the operating pipe deformed and broke because the slider was forcefully operated.4) due to above, the loop could not detach from the hook.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: 21665154
• Report Number: 9614641-2025-00350
• Device Sequence Number: 7624827
• Product Code: MND
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 04/17/2025

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 Expiration Date: 09/30/2026
• Device Model Number: HX-400U-30
• Device Lot Number: 3XV 23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE UNKNOWN MANUFACTURER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown