FDA Adverse Event
Malfunction
Summary report: N
SENSATION SHORT THROW
MDR report key: 8222444
·
Received January 4, 2019
Report
- Report Number
- MW5082883
- Event Type
- Malfunction
- Date Received
- January 4, 2019
- Date of Event
- December 28, 2018
- Report Date
- January 2, 2019
- Manufacturer
- BOSTON SCIENTIFIC CORP.
- Product Code
- FDI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
ENDO TECH WAS UNABLE TO GET SNARE OPEN DURING PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9803 | SENSATION SHORT THROW | POLYPECTOMY SNARE FLEXIBLE | FDI | BOSTON SCIENTIFIC CORP. | 21430327 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |