FDA Adverse Event
Malfunction
Summary report: N
ENDOWRIST
MDR report key: 23519733
·
Received November 11, 2025
Report
- Report Number
- 2955842-2025-44678
- Event Type
- Malfunction
- Date Received
- November 11, 2025
- Date of Event
- October 19, 2025
- Report Date
- November 11, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K214095
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
CORRECTION: REPRESENTATIVE LEARNED OF THE ISSUE ON 10/19/2025. REPORTABILITY AWARENESS DATE HAS BEEN UPDATED TO 10/19/2025. EVENT DATE WAS UPDATED BASED ON INFORMATION FROM CUSTOMER.
Additional Manufacturer Narrative · 0
INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.
Description of Event or Problem · 0
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN EQUIPMENT FAILURE OCCURRED INVOLVING THE INSULATION PAD OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT, WHICH BURNED, SMOKED, AND MELTED. PROCEDURE OUTCOME IS UNKNOWN AT THE TIME OF THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1878379 | ENDOWRIST | MARYLAND BIPOLAR FORCEPS | NAY | INTUITIVE SURGICAL, INC | 471172-19 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES. |