FDA Adverse Event
Malfunction
Summary report: N
SPIDER
MDR report key: 2862309
·
Received November 27, 2012
Report
- Report Number
- 2862309
- Event Type
- Malfunction
- Date Received
- November 27, 2012
- Date of Event
- November 20, 2012
- Report Date
- November 27, 2012
- Manufacturer
- TRANSENTERIX, INC.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPIDER | LAPAROSCOPE | GCJ | TRANSENTERIX, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR |