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

Model Number	HX-400U-30
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a diagnostic colonoscopy, the single use ligating device may not have been deployed correctly.Upon further follow up, the customer indicated that the device anchored itself around the patient's tissue.The proceduralist could not remove it for a prolonged period because the slider part of the device detached from the operation wire.The procedure was completed with the same device with a delay greater than or equal to 30 minutes.There were no reports of further patient harm.Additional information was requested including further patient details, outcome, and method of device removal, but no customer response has been received at this time.

• Brand Name: SINGLE USE LIGATING DEVICE
• Common Device Name: SINGLE USE LIGATING DEVICE
• Manufacturer (Section D): OLYMPUS VIETNAM CO. LTD.; 8 street, long thanh ind. zone; an phuoc commune; dong nai province 81000 0; VM 810000
• MDR Report Key: 24857457
• Report Number: 2429304-2026-00035
• Device Sequence Number: 16089285
• Product Code: MND
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2026
• Report Date (Section F): 04/13/2026

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/24/2026
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/13/2026