FDA Adverse Event
Injury
Summary report: N
DA VINCI
MDR report key: 24131629
·
Received January 21, 2026
Report
- Report Number
- 2955842-2025-50538
- Event Type
- Injury
- Date Received
- January 21, 2026
- Report Date
- January 21, 2026
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- GCJ
- PMA / PMN Number
- K181395
- Removal / Correction Number
- N/A
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PORTION OF THE CANNULA SEAL WAS IDENTIFIED INSIDE THE PATIENT. THE FOLLOWING INFORMATION IS UNKNOWN: THE EVENT DATE, IF THE FRAGMENT WAS RETRIEVED, AND THE PROCEDURE/PATIENT OUTCOME. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196181 | DA VINCI | SEAL | GCJ | INTUITIVE SURGICAL, INC | 470500-13 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other | DA VINCI INSTRUMENTS AND ACCESSORIES |