MAUDE Adverse Event Report: HANGZHOU AGS MEDTECH LASSO POLYPECTOMY SNARE

Model Number	1180-12
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
No adverse event related to this incident.It was reported to diversatek healthcare 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.

• Brand Name: LASSO POLYPECTOMY SNARE
• Common Device Name: POLYPECTOMY SNARE
• Manufacturer (Section D): HANGZHOU AGS MEDTECH; building 6, kangxin rd no 597; qianjiang economic dev area; hangzhou, zhejiang 31110 6; CH 311106
• MDR Report Key: 23416816
• Report Number: 2183446-2025-00001
• Device Sequence Number: 10408333
• Product Code: FDI
• UDI-Device Identifier: 00816734023020
• UDI-Public: 00816734023020
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/29/2025
• Report Date (Section F): 10/29/2025

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
• Device Model Number: 1180-12
• Device Catalogue Number: 1180-12
• Device Lot Number: 098282
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/27/2025
• Device Age: 4 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/29/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/29/2025