FDA Adverse Event
Injury
Summary report: N
DAVINCI MONOPOLAR CURVED SCISSORS
MDR report key: 22913330
·
Received August 28, 2025
Report
- Report Number
- MW5175330
- Event Type
- Injury
- Date Received
- August 28, 2025
- Date of Event
- August 13, 2025
- Report Date
- August 22, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC.
- Product Code
- NAY
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NC, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
MONOPOLAR SCISSORS FAILED TO CUT, NOT AT END OF LIFE. INSTRUMENT WAS REMOVED, REPLACED WITH NEW MONOPOLAR SCISSORS WHICH WORKED AS INTENDED. MANUFACTURED DATE 04-03-2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2164004 | DAVINCI MONOPOLAR CURVED SCISSORS | SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT | NAY | INTUITIVE SURGICAL, INC. | 470179 | K12250403 0246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Female | Required Intervention |