• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HANGZHOU AGS MEDTECH CO., LTD. LASSO; POLYPECTOMY SNARE Back to Search Results
Model Number 1180-11
Device Problems Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/17/2023
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 biospy forceps and no patient injury was noted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key16861524
MDR Text Key314482524
Report Number2183446-2023-00004
Device Sequence Number1
Product Code FDI
UDI-Device Identifier00816734021613
UDI-Public00816734021613
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/03/2023
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 Operator Health Professional
Device Model Number1180-11
Device Catalogue Number1180-11
Device Lot Number041929
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/03/2023
Distributor Facility Aware Date04/17/2023
Device Age11 MO
Event Location Hospital
Date Report to Manufacturer04/18/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/03/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-