BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI X

    MDR report key: 14305819 · Received May 6, 2022

    Report

    Report Number
    2955842-2022-11431
    Event Type
    Death
    Date Received
    May 6, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 5, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    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 · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S DEATH IS UNKNOWN. ISI HAS ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT/INCIDENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. THE SURGEON STATES THAT THE EVENTS ARE NOT ATTRIBUTABLE TO THE ROBOTIC PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SYSTEM LOGS FOR THE PROCEDURE DATE OF (B)(6) 2022 HAS BEEN PERFORMED BY AN ISI TECHNICAL SUPPORT ENGINEER (TSE) AND THE FOLLOWING WAS OBSERVED: MULTIPLE PROCEDURES HAVE BEEN PERFORMED ON THIS SYSTEM AFTER THIS REPORTED COMPLAINT WITH NO SERVICE REQUESTS BEING CREATED. NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. AS A RESULT OF THIS REVIEW, THE TSE DID NOT RECOMMEND FOR AN ISI FIELD SERVICE ENGINEER (FSE) TO VISIT THE SITE TO PERFORM SYSTEM VERIFICATION TESTING. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE EVENT WAS CONDUCTED BY AN ISI MEDICAL SAFETY OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: BASED UPON THE INFORMATION CONTAINED IN THE DESCRIPTION OF EVENTS, THE EXTENT THAT THE DA VINCI SYSTEM, INSTRUMENTATION, AND/OR ACCESSORIES CAUSED OR CONTRIBUTED TO THE PATIENT¿S MORTALITY IS UNKNOWN. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED NEPHROURETERECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON THE SAME DAY OF THE PROCEDURE. AT THIS TIME, THE CAUSE OF PATIENT'S DEATH IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED NEPHROURETERECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON THE SAME DAY OF THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON INDICATED, "THE EVENTS ARE NOT ATTRIBUTABLE TO THE ROBOTIC PROCEDURE ITSELF." FURTHERMORE, THE SURGEON INDICATED, "IT APPEARS THAT THE CAUSE OF DEATH WAS MULTIVISCERAL FAILURE." NO FURTHER CLINICAL INFORMATION WAS PROVIDED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073016 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-42 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES