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

Model Number 1180-12

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2023

Event Type  malfunction  

Event 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 with a biopsy forceps and no patient injury was noted.

• Brand Name: LASSO
• Type of Device: 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: 16364994
• MDR Text Key: 309424782
• Report Number: 2183446-2023-00003
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 00816734023020
• UDI-Public: 00816734023020
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1180-12
• Device Catalogue Number: 1180-12
• Device Lot Number: 034921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2023
• Distributor Facility Aware Date: 01/19/2023
• Device Age: 15 MO
• Event Location: Other
• Date Report to Manufacturer: 01/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1