FDA Adverse Event
Malfunction
Summary report: N
ENDOWRIST
MDR report key: 22548705
·
Received July 18, 2025
Report
- Report Number
- 2955842-2025-30814
- Event Type
- Malfunction
- Date Received
- July 18, 2025
- Date of Event
- May 20, 2025
- Report Date
- August 4, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874119785
- PMA / PMN Number
- K214095
- Removal / Correction Number
- ISIFA2024-09-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PROGRASP FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE DISTAL END. THE COMPLAINT REGARDING A BROKEN CABLE WAS CONFIRMED BY FAILURE ANALYSIS.
Additional Manufacturer Narrative · 0
THE FOLLOWING FIELDS NEED TO BE CORRECTED FOR THE INITIAL MDR THAT WAS PREVIOUSLY SUBMITTED FOR THIS EVENT: B4. DATE OF THIS REPORT: 06/03/2025. G3. DATE RECEIVED BY MFR: 06/03/2025.
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 |
|---|---|---|---|---|---|---|---|
| 1419929 | ENDOWRIST | PROGRASP FORCEPS | NAY | INTUITIVE SURGICAL, INC | 471093-11 | K11240222 0064 | 00886874119785 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |