ENDOWRIST
Report
- Report Number
- 2955842-2025-33915
- Event Type
- Injury
- Date Received
- August 13, 2025
- Date of Event
- July 25, 2025
- Report Date
- July 25, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 10886874112738
- PMA / PMN Number
- K143132
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS.
UPDATED FIELDS: D9, H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) THE HARMONIC ACE INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE CURVED BLADE BROKEN AT THE BASE. A PIECE APPROXIMATELY 0.509" X 0.084" WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED. COMPONENTS ADJACENT TO THE BROKEN BLADE DID NOT SHOW DAMAGE.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A JAW OF THE HARMONIC ACE BROKE OFF WHEN POWER WAS APPLIED TO THE DEVICE. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 563459 | ENDOWRIST | HARMONIC ACE | NAY | INTUITIVE SURGICAL, INC | 480275-08 | L80240222 | 10886874112738 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | DA VINCI INSTRUMENTS AND ACCESSORIES. |