ENDOWRIST
Report
- Report Number
- 2955842-2025-44586
- Event Type
- Malfunction
- Date Received
- November 8, 2025
- Date of Event
- October 14, 2025
- Report Date
- November 27, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874119808
- PMA / PMN Number
- K214095
- Removal / Correction Number
- ISIFA2024-09-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A REVIEW OF CUSTOMER PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL INC., (ISI) ADVANCED FAILURE ANALYSIS (AFA) TEAM. FOLLOWING INFORMATION WAS PROVIDED : THE GRIP CABLE ON INSTRUMENT APPEARS TO BE BROKEN. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT; HOWEVER, FAILURE ANALYSIS INVESTIGATIONS ARE UNDER PROGRESS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.
THE INSTRUMENT INVOLVED IN THIS COMPLAINT HAS BEEN RECEIVED AND TESTED BY FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A DAMAGED GRIP CABLE.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS OBSERVED TO HAVE A BROKEN CABLE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171634 | ENDOWRIST | FENESTRATED BIPOLAR FORCEPS | NAY | INTUITIVE SURGICAL, INC | 471205-17 | K10240606 0481 | 00886874119808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES. |