FDA Adverse Event
Malfunction
Summary report: N
ENDOWRIST
MDR report key: 22074356
·
Received May 22, 2025
Report
- Report Number
- 2955842-2025-21732
- Event Type
- Malfunction
- Date Received
- May 22, 2025
- Date of Event
- March 13, 2025
- Report Date
- April 30, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874112311
- PMA / PMN Number
- K131861
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 PITCH CABLE.
Additional Manufacturer Narrative · 0
CORRECTION : ANNEX CODE B WAS CHANGED TO B01, ANNEX C WAS CHANGED TO C070603 AND, ANNEX D WAS CHANGED TO D02.
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 |
|---|---|---|---|---|---|---|---|
| 2366310 | ENDOWRIST | PERMANENT CAUTERY HOOK | NAY | INTUITIVE SURGICAL, INC | 470183-18 | K11240801 0193 | 00886874112311 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES. |