FDA Adverse Event
Malfunction
Summary report: N
ENDOWRIST
MDR report key: 21588777
·
Received March 12, 2025
Report
- Report Number
- 2955842-2025-07584
- Event Type
- Malfunction
- Date Received
- March 12, 2025
- Date of Event
- December 2, 2024
- Report Date
- February 15, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874119792
- PMA / PMN Number
- K214095
- Removal / Correction Number
- ISIFA2024-09-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS JAD A PULLEY BROKEN. THERE WERE NO DELAYS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1616055 | ENDOWRIST | MARYLAND BIPOLAR FORCEPS | NAY | INTUITIVE SURGICAL, INC | 471172-17 | K11240201 0074 | 00886874119792 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES. |