FDA Adverse Event
Injury
Summary report: N
ENDOWRIST
MDR report key: 23802221
·
Received December 15, 2025
Report
- Report Number
- 2955842-2025-48369
- Event Type
- Injury
- Date Received
- December 15, 2025
- Date of Event
- November 20, 2025
- Report Date
- December 15, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K214095
- Removal / Correction Number
- ISIFA2024-09-C
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION.
Description of Event or Problem · 0
DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE CONTACTED TECHNICAL SUPPORT TO REPORT THEY HAD A FORCE BIPOLAR INSTRUMENT FAIL AND THE CABLING AT THE WRIST WAS FRAYED OUT. THE SURGEON WAS UNSURE IF A FRAGMENT FELL INTO THE PATIENT. THEY WERE GOING TO PERFORM AN X-RAY TO VERIFY. THE CUSTOMER REPLACED THE DAMAGED INSTRUMENT WITH A BACKUP, AND THEY CONTINUED AS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324476 | ENDOWRIST | FORCE BIPOLAR | NAY | INTUITIVE SURGICAL, INC | 471405-06 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | DA VINCI INSTRUMENTS AND ACCESSORIES. |