FDA Adverse Event
Malfunction
Summary report: N
INTUITIVE SURGICAL INC
MDR report key: 7685081
·
Received July 12, 2018
Report
- Report Number
- MW5078351
- Event Type
- Malfunction
- Date Received
- July 12, 2018
- Date of Event
- June 5, 2018
- Report Date
- July 2, 2018
- Manufacturer
- INTUITIVE SURGICAL INC
- Product Code
- NAY
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
SCISSOR PART OF NEEDLE DRIVER DULL, WOULD NO LONGER CUT SUTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 525919 | INTUITIVE SURGICAL INC | DA VINCI SI LARGE SUTURECUT NEEDLE DRIVER | NAY | INTUITIVE SURGICAL INC | DA VINCI SI | N10170808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |