MAUDE Adverse Event Report: HANGZHOU AGS MEDTECH LASSO; POLYPECTOMY SNARE

Model Number	1180-14
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
No adverse event related to this incident.As the snare was closing around the polyp, the snare wire broke off from the catheter.The wire piece was retrieved and no patient injury was noted.

• Brand Name: LASSO
• 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: 19609915
• Report Number: 2183446-2024-00003
• Device Sequence Number: 6236845
• Product Code: FDI
• UDI-Device Identifier: 00816734023044
• UDI-Public: 00816734023044
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/25/2024
• Report Date (Section F): 06/25/2024

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: 1180-14
• Device Catalogue Number: 1180-14
• Device Lot Number: 075257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/11/2024
• Device Age: 18 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• 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: 06/25/2024