Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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. LASOO; 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. LASOO; POLYPECTOMY SNARE Back to Search Results
Model Number 1180-03
Device Problem Use of Device Problem (1670)
Patient Problem Perforation (2001)
Event Date 11/28/2022
Event Type  Injury  
Event 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 (sigmoid and rectal).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 4 days total.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LASOO
Type of Device
POLYPECTOMY SNARE
Manufacturer (Section D)
HANGZHOU AGS MEDTECH CO., LTD.
building 6, kangxin rd no 597
qianjiang economoci dev area
hangzhou, zhejiang 31110 6
CH  311106
MDR Report Key16112415
MDR Text Key306801593
Report Number2183446-2023-00002
Device Sequence Number1
Product Code FDI
UDI-Device Identifier00816734021583
UDI-Public00816734021583
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 01/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1180-03
Device Catalogue Number1180-03
Device Lot Number029284
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/06/2023
Distributor Facility Aware Date12/08/2022
Device Age15 MO
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer12/13/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-