FDA Adverse Event
Injury
Summary report: N
ENDO WRIST VESSEL SEALER
MDR report key: 3080398
·
Received April 23, 2013
Report
- Report Number
- MW5029931
- Event Type
- Injury
- Date Received
- April 23, 2013
- Date of Event
- April 10, 2013
- Report Date
- April 17, 2013
- Manufacturer
- INTUITIVE SURGICAL INC
- Product Code
- NAY
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MD, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DA VINCI VESSEL SEAL 8 MM - THE CAUTERY ASPECT OF DEVICE NOT WORKING PROPERLY. DA VINCI VESSEL SEAL 8 MM - THE DISTAL END OF DEVICE - THE SPRING ASPECT - MALFUNCTIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175198 | ENDO WRIST VESSEL SEALER | NONE | NAY | INTUITIVE SURGICAL INC | 410322 | S11121217 | |
| 175199 | ENDO WRIST VESSEL SEALER | NONE | NAY | INTUITIVE SURGICAL INC | 410322 | 10121107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |