FDA Adverse Event
Malfunction
Summary report: N
ENDOWRIST
MDR report key: 21895354
·
Received April 23, 2025
Report
- Report Number
- 2955842-2025-16532
- Event Type
- Malfunction
- Date Received
- April 23, 2025
- Date of Event
- March 5, 2025
- Report Date
- April 2, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874119815
- PMA / PMN Number
- K214095
- Removal / Correction Number
- ISIFA2024-09-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE INSTRUMENT INVOLVED IN THIS COMPLAINT HAS BEEN RECEIVED AND TESTED BY FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A DAMAGED GRIP CABLE.
Additional Manufacturer Narrative · 0
CORRECTION TO ANNEX CODES: - ANNEX CODE G WAS UPDATED TO G04121. - ANNEX CODE C WAS UPDATED TO C070603. - ANNEX CODE D WAS UPDATED TO D02.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 727098 | ENDOWRIST | MEGA SUTURECUT ND | NAY | INTUITIVE SURGICAL, INC | 471309-16 | K11230810 0172 | 00886874119815 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES. |