BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1882151 · Received October 25, 2010

    Report

    Report Number
    2955842-2010-00462
    Event Type
    Death
    Date Received
    October 25, 2010
    Report Date
    July 23, 2025
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON HAS INDICATED THAT THE PATIENT'S DEATH WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM WORKED AS INTENDED AND NO SYSTEM MALFUNCTIONS OCCURRED. AS OF OCTOBER 22, 2010, NO SIMILAR INSTANCES OF THIS EVENT HAVE BEEN REPORTED TO INTUITIVE SURGICAL. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    WHILE GATHERING INFORMATION FOR A STUDY, THE SURGEON WAS MADE AWARE OF 3 EVENTS THAT OCCURRED 4 TO 7 DAYS POST A DA VINCI S TORS PROCEDURE WHERE THE PATIENT EXPIRED SECONDARY TO COMPLICATION RELATED TO THEIR CANCER. SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION WITHOUT SUCCESS. FOR THESE SIMILAR EVENTS, PLEASE SEE MDR'S 2955842-2010-00460 AND 2955842-2010-00461.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE INITIAL REPORTER PROVIDED ADDITIONAL INFORMATION RELATED TO THIS EVENT. HE ADVISED THAT THE PATIENT UNDERWENT A DA VINCI S PARTIAL LARYNGECTOMY PROCEDURE AND EXPERIENCED BLEEDING FROM THE LARYNGEAL ARTERY 5 DAYS POST OP. THE PATIENT HAD ASPIRATED BLOOD AND A SECONDARY SURGERY WAS PERFORMED TO SUCCESSFULLY CONTROL THE BLEEDING. THE PATIENT WAS ENTUBATED AND EXPIRED 1 TO 2 DAYS LATER DUE TO A CHEST INFECTION FROM THE ASPIRATION. THE INITIAL REPORTER ADVISED THAT THE PATIENT'S DEATH WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death DA VINCI INSTRUMENTS AND ACCESSORIES| DA VINCI S SYSTEM INSTRUMENTS, ACCESSORIES & ESU| DA VINCI S SYSTEM INSTRUMENTS, ACCESSORIES & ESU