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

Model Number	HX-400U-30
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a colonoscopy, while performing a polypectomy, the loop of the ligating device was unable to detach, and the cannula/deployment device was unable to be withdrawn after the device was deployed.The slider located on the device handle could not move forward or backward.The operating wire had to be cut to remove the device from the patient/scope.The hot snare was required to remove the stuck polyp loop.The scope was removed and reinserted.An endoscopic submucosal dissection was performed to complete the procedure.In addition, it was reported that the lesion was a 30 mm pedunculated polyp on a stalk located in the sigmoid colon.The procedure was delayed for about 75 minutes, and the patient was under general anesthesia with propofol.The patient remained hemodynamically stable and was admitted to the hospital for observation due to the length of the procedure time and extensive polypectomy to ensure no bleeding.The patient was discharged in stable condition.This report is 2 of 2.

• 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: 25156699
• Report Number: 2429304-2026-00054
• Device Sequence Number: 9454108
• Product Code: MND
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2026
• Report Date (Section F): 05/12/2026

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 Model Number: HX-400U-30
• Device Lot Number: 41V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/16/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/12/2026