FDA Adverse Event
Injury
Summary report: N
LASOO
MDR report key: 16112415
·
Received January 6, 2023
Report
- Report Number
- 2183446-2023-00002
- Event Type
- Injury
- Date Received
- January 6, 2023
- Date of Event
- November 28, 2022
- Report Date
- January 6, 2023
- Manufacturer
- HANGZHOU AGS MEDTECH CO., LTD.
- Product Code
- FDI
- UDI-DI
- 00816734021583
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- TX, US
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1393029 | LASOO | POLYPECTOMY SNARE | FDI | HANGZHOU AGS MEDTECH CO., LTD. | 1180-03 | 029284 | 00816734021583 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization| R |