MAUDE Adverse Event Report: HANGZHOU AGS MEDTECH CO., LTD. LASSO; POLYPECTOMY SNARE

Model Number	1180-02
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported this adverse event to importer on december 8, 2022.Customer reported a perforation during the removal of polyps from the colon.The procedure being performed was a colonscopy with a polypectomy x 2 (hepatic flexure and sigmoid).The adverse event required a reported surgical intervention to repair the perforation.The patient had no reported underlying health issues that may have contributed to the event.The patient was hospitalized for 9 days total.

• Brand Name: LASSO
• 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
• MDR Report Key: 16112410
• Report Number: 2183446-2023-00001
• Device Sequence Number: 15170395
• Product Code: FDI
• UDI-Device Identifier: 00816734021576
• UDI-Public: 00816734021576
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/06/2023
• Report Date (Section F): 01/06/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2025
• Device Model Number: 1180-02
• Device Catalogue Number: 1180-02
• Device Lot Number: 041926
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/08/2022
• Device Age: 9 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 12/13/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/06/2023