FDA Adverse Event
Malfunction
Summary report: N
ENDOWRIST
MDR report key: 21981068
·
Received May 7, 2025
Report
- Report Number
- 2955842-2025-19530
- Event Type
- Malfunction
- Date Received
- May 7, 2025
- Date of Event
- April 18, 2025
- Report Date
- April 18, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874112496
- PMA / PMN Number
- K131861
- Removal / Correction Number
- ISIFA2024-09-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
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
CORRECTION TO ANNEX CODES: ANNEX B WAS UPDATED TO B01. ANNEX C WAS UPDATED TO C070603. ANNEX D WAS UPDATED TO D02.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS A FRAYED 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144504 | ENDOWRIST | TIP-UP FENESTRATED GRASPER | NAY | INTUITIVE SURGICAL, INC | 470347-11 | K10240222 0134 | 00886874112496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |