FDA Adverse Event
Malfunction
Summary report: N
ENSEAL PTC
MDR report key: 1667522
·
Received April 22, 2010
Report
- Report Number
- 1667522
- Event Type
- Malfunction
- Date Received
- April 22, 2010
- Date of Event
- April 12, 2010
- Report Date
- April 22, 2010
- Manufacturer
- SURGRX, INC
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY, US
Narratives
Description of Event or Problem · 1
ENSEAL STOPPED WORKING DURING THE CASE. A NEW ENSEAL WAS OPENED AND THE CASE PROCEEDED WITHOUT FURTHER OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENSEAL PTC | TISSUE SEALING DEVICE | GEI | SURGRX, INC | * | F10A21-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |