FDA Adverse Event
Malfunction
Summary report: N
ENDOWRIST
MDR report key: 24990505
·
Received April 24, 2026
Report
- Report Number
- 2955842-2026-22566
- Event Type
- Malfunction
- Date Received
- April 24, 2026
- Date of Event
- March 26, 2026
- Report Date
- April 24, 2026
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874120767
- PMA / PMN Number
- K214095
- Removal / Correction Number
- ISIFA2024-09-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE FORCE BIPOLAR INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE INSTRUMENT WAS FOUND TO HAVE A FRAYED GRIP CABLE AT THE DISTAL END.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, FORCE BIPOLAR FORCEPS INSTRUMENT WAS OBSERVED TO HAVE A BROKEN CONDUCTOR WIRE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568485 | ENDOWRIST | FORCE BIPOLAR | NAY | INTUITIVE SURGICAL, INC | 471405-06 | K10250619 0069 | 00886874120767 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |