FDA Adverse Event
Malfunction
Summary report: N
ENDOWRIST
MDR report key: 24677257
·
Received March 24, 2026
Report
- Report Number
- 2955842-2026-17715
- Event Type
- Malfunction
- Date Received
- March 24, 2026
- Date of Event
- February 27, 2026
- Report Date
- March 24, 2026
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874112298
- PMA / PMN Number
- K220023
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INTUITIVE SURGICAL INC. (ISI), HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING CENTRAL PROCESSING PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT EXHIBITED A HEAT STAINING, THE OR IS NOT COMFORTABLE USING THESE SCISSORS WITH STAINING BECAUSE THEY CANNOT TELL IF IT IS BIOBURDEN OR NOT. THE CUSTOMER REPORTED EVENT HAD NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 734680 | ENDOWRIST | MONOPOLAR CURVED SCISSORS | NAY | INTUITIVE SURGICAL, INC | 470179-23 | N/A | 00886874112298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |