FDA Adverse Event
Malfunction
Summary report: N
ENDOWRIST
MDR report key: 21682915
·
Received March 24, 2025
Report
- Report Number
- 2955842-2025-11302
- Event Type
- Malfunction
- Date Received
- March 24, 2025
- Date of Event
- December 2, 2024
- Report Date
- March 6, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874112267
- PMA / PMN Number
- K131861
- Removal / Correction Number
- ISIFA2024-09-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
CORRECTION TO ANNEX CODES: - ANNEX C WAS UPDATED TO C070603. - ANNEX D WAS UPDATED TO D02.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 707168 | ENDOWRIST | PROGRASP FORCEPS | NAY | INTUITIVE SURGICAL, INC | 470093-11 | K10240327 0395 | 00886874112267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES. |