FDA Adverse Event
Malfunction
Summary report: N
ENDOWRIST
MDR report key: 22343270
·
Received June 27, 2025
Report
- Report Number
- 2955842-2025-27551
- Event Type
- Malfunction
- Date Received
- June 27, 2025
- Date of Event
- June 16, 2025
- Report Date
- June 16, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874119808
- PMA / PMN Number
- K214095
- Removal / Correction Number
- ISIFA2024-09-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
AT THIS TIME, THE COMPLAINT INVESTIGATION TO DETERMINE THE CAUSE OF THIS REPORTED EVENT IS CURRENTLY IN PROGRESS. AS SUCH, THE PROBABLE ROOT CAUSE CANNOT YET BE DETERMINED BASED ON THE INFORMATION PROVIDED. THE COMPLAINT WILL BE REEVALUATED AT INVESTIGATION COMPLETION.
Additional Manufacturer Narrative · 0
THE FOLLOWING FIELD ANNEX A CODE HAS BEEN UPDATED TO "A040605 - MATERIAL FRAYED" AS A CORRECTION.
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 THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Description of Event or Problem · 0
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Description of Event or Problem · 0
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1845572 | ENDOWRIST | FENESTRATED BIPOLAR FORCEPS | NAY | INTUITIVE SURGICAL, INC | 471205-17 | K11241009 0294 | 00886874119808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES. |