FDA Adverse Event
Malfunction
Summary report: N
ENDOWRIST
MDR report key: 21673905
·
Received March 23, 2025
Report
- Report Number
- 2955842-2025-10589
- Event Type
- Malfunction
- Date Received
- March 23, 2025
- Date of Event
- December 23, 2024
- Report Date
- March 6, 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
- HK
- Reporter Occupation
- 003
Narratives
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.
Additional Manufacturer Narrative · 0
ANNEX CODE C WAS UPDATED TO C070603.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Description of Event or Problem · 0
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 862987 | ENDOWRIST | MONOPOLAR CURVED SCISSORS | NAY | INTUITIVE SURGICAL, INC | 470179-19 | K19230427 0279 | 00886874112298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |