ENDOWRIST
Report
- Report Number
- 2955842-2025-32026
- Event Type
- Malfunction
- Date Received
- July 29, 2025
- Date of Event
- April 29, 2025
- Report Date
- November 18, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874112298
- PMA / PMN Number
- K220023
- Removal / Correction Number
- ISIFA2024-09-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INSTRUMENT INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED AND/OR TESTED BY FAILURE ANALYSIS AS OF THE DATE OF THIS REPORT. IF THE PRODUCT IS RECEIVED AND EVALUATED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.
THE INSTRUMENT INVOLVED IN THIS COMPLAINT HAS BEEN RECEIVED AND TESTED BY FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A DAMAGED GRIP CABLE.
CORRECTION(S): B3. WAS UPDATED FROM 07/09/2025 TO 04/29/2025 TO REFLECT THE RELATED RECORD AS THE SAME EVENT WAS REPORTED TWICE. H8. WAS UPDATED TO INITIAL USE OF DEVICE. ANNEX A - DEVICE PROB DESC 1 WAS UPDATED FROM A25 - NO APPARENT ADVERSE EVENT TO A090205 - IMAGE ORIENTATION INCORRECT. ANNEX F - HEALTH IMPACT DESC 1 WAS UPDATED FROM F24 - INSUFFICIENT HEALTH IMPACT INFORMATION TO F26 - NO HEALTH CONSEQUENCES OR IMPACT. RELATED REPORT NUMBER 1 (H10) WAS UPDATED TO 2955842-2025-24663.
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1161054 | ENDOWRIST | MONOPOLAR CURVED SCISSORS | NAY | INTUITIVE SURGICAL, INC | 470179-19 | K14240606 0719 | 00886874112298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |