ENDOWRIST
Report
- Report Number
- 2955842-2026-14976
- Event Type
- Malfunction
- Date Received
- March 4, 2026
- Date of Event
- February 6, 2026
- Report Date
- April 24, 2026
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874119785
- PMA / PMN Number
- K214095
- Removal / Correction Number
- ISIFA2024-09-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INTUITIVE SURGICAL INC. (ISI), HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PROGRASP FORCEPS INSTRUMENT WAS ANALYZED AND THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM: THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE INSTRUMENT GRIP TIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED THE GRIP TEST. THE INSTRUMENT PASSED THE BUMPER TEST. THE BACKLASH OF THE GRIPS IS DUE TO THE DESIGN AND WITHIN THE SPECIFIED LIMITS. NO PRODUCT ISSUE WAS FOUND. THE INSTRUMENT WAS FULLY FUNCTIONAL.
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CABLE IS BROKEN WHICH WEAKENS THE JAWS.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 107427 | ENDOWRIST | PROGRASP FORCEPS | NAY | INTUITIVE SURGICAL, INC | 471093-11 | K10230803 0029 | 00886874119785 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES. |