FDA Adverse Event
Malfunction
Summary report: N
DA VINCI
MDR report key: 24868170
·
Received April 14, 2026
Report
- Report Number
- 2955842-2026-21408
- Event Type
- Malfunction
- Date Received
- April 14, 2026
- Date of Event
- March 23, 2026
- Report Date
- April 13, 2026
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874120873
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- NURSE
- Health Professional
- Yes
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 A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT DIDN'T WORK AS IT SHOULD DURING ACTIVATION. NOT PROPER SYNC-SEAL EFFECT WITH TISSUE DURING ACTIVATION. EXPERIENCED SURGEONS HAD USED SS VIA E-100 GENERATOR BEFORE MULTIPLE YEARS. THE SAME ISSUE HAPPENED WITH DIFFERENT SS INSTRUMENTS AND WITH DIFFERENT PATIENTS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 101289 | DA VINCI | VISION SIDE SYSTEM | NAY | INTUITIVE SURGICAL, INC | 374897-41 | N/A | 00886874120873 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |