ENDOWRIST
Report
- Report Number
- 2955842-2025-30483
- Event Type
- Injury
- Date Received
- July 21, 2025
- Date of Event
- June 12, 2025
- Report Date
- July 8, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874121504
- PMA / PMN Number
- K214095
- Removal / Correction Number
- ISIFA2024-09-C
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- 003
Narratives
THE NEEDLE DRIVER INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION.
INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE BLADE DAMAGE AT THE MIDPOINT OF BOTH BLADES. THE BLADES EDGES WERE INDENTED AND DULL PREVENTING INSTRUMENT FROM CUTTING. THE CUTTING EDGE DID NOT EXHIBIT ANY SIGNS OF CORROSION THAT WOULD HAVE CONTRIBUTED TO THE BLADE DAMAGE.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE NEEDLE DRIVER INSTRUMENT DIDN'T "CUT". A FRAGMENT FELL INTO THE PATIENT AND WAS NOT RETRIEVED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1939055 | ENDOWRIST | LARGE SUTURE CUT NEEDLE DRIVER | NAY | INTUITIVE SURGICAL, INC | 471296-07 | N10201123 0097 | 00886874121504 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other | DA VINCI INSTRUMENTS AND ACCESSORIES |