FDA Adverse Event
Malfunction
Summary report: N
DI VANCI SURGICAL
MDR report key: 4092954
·
Received September 10, 2014
Report
- Report Number
- MW5038170
- Event Type
- Malfunction
- Date Received
- September 10, 2014
- Date of Event
- August 15, 2014
- Report Date
- September 10, 2014
- Manufacturer
- INTUITIVE SURGICAL
- Product Code
- NAY
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
ROBOTIC SCISSOR PROTECTOR FRAYED/TORE AT THE END OF THE PROCEDURE. NO INJURY TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559681 | DI VANCI SURGICAL | ROBOTIC SCISSOR | NAY | INTUITIVE SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |