MAUDE Adverse Event Report: Hangzhou AGS MedTech CO., LTD. LASSO POLYPECTOMY SNARE

Model Number	1180-14
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	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
No adverse event related to this incident.It was reported to (b)(6) that a cold only snare completely broke off inside of a patient while trying to cut a polyp.The whole loop fell off when the snare was closed.The wire piece was retrieved and no patient injury was noted.
Additional Manufacturer Narrative
According to the photo analysis provided by the customer, it is possible that the production personnel may miss welding, leading to the separation of the snare and the traction rope.It is an isolated case.

• Brand Name: LASSO POLYPECTOMY SNARE
• Common Device Name: POLYPECTOMY SNARE
• Manufacturer (Section D): Hangzhou AGS MedTech CO., LTD.; building 6, kangxin rd no 597; qianjiang economic dev area; hangzhou, zhejiang 31110 6; CH 311106
• Manufacturer (Section G): HANGZHOU AGS MEDTECH CO., LTD.; building 6, kangxin rd no 597; qianjiang economic dev area; hangzhou, zhejiang 31110 6; CH 311106
• Manufacturer Contact: yu jiao ; building 6, kangxin rd no 597; qianjiang economic dev area; hangzhou, zhejiang 31110-6 ; CH 311106
• MDR Report Key: 50065887
• Report Number: 3010288205-2026-00001
• Device Sequence Number: 13382177
• Product Code: FDI
• UDI-Device Identifier: 06959664902165
• UDI-Public: 06959664902165
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1180-14
• Device Catalogue Number: 533
• Device Lot Number: 097953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2025
• 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: Hospitalization
• Patient Sex: Unknown