BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 9281634 · Received November 5, 2019

    Report

    Report Number
    2955842-2019-10877
    Event Type
    Death
    Date Received
    November 5, 2019
    Date of Event
    September 20, 2019
    Report Date
    October 10, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES MANAGER (CSM) CONTACTED A NURSE FROM THE SITE AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: AFTER THE DA VINCI-ASSISTED SURGICAL PROCEDURE INVOLVING THE PATIENT¿S BLADDER WAS COMPLETED AND THE ROBOT WAS UNDOCKED FROM THE PATIENT, A PLANNED CONVERSION WAS PERFORMED. WHILE ONE SURGEON WAS WORKING IN THE ABDOMEN AND ANOTHER SURGEON WAS OPERATING ON THE PERINEUM, AN UNSPECIFIED VESSEL WAS DAMAGED. THE NURSE INDICATED THAT THE DAMAGED VESSEL WAS THE CAUSE OF THE PATIENT¿S DEATH. ON (B)(6) 2019, AN ISI CLINICAL SALES REPRESENTATIVE (CSR) SPOKE TO THE SITE¿S DIRECTOR OF THE UROLOGY DEPARTMENT, A PHYSICIAN, AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT HAD UNDERGONE A DA VINCI-ASSISTED SURGICAL PROCEDURE FOR BLADDER CANCER AND THE ROBOT WAS LATER UNDOCKED FROM THE PATIENT. THE PHYSICIAN INDICATED THAT HE DID NOT DAMAGE A BLOOD VESSEL AS REPORTED BY THE NURSE. HOWEVER, HE EXPLAINED THAT THE SURGERY TIME TOOK TOO LONG WHICH WAS NOT GOOD. ADDITIONALLY, THE PHYSICIAN INDICATED THAT ¿ANESTHESIOLOGY WAS BAD.¿ BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT IS NO LONGER DEEMED REPORTABLE DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED PROCEDURE FOR BLADDER CANCER, A PLANNED CONVERSION WAS PERFORMED. DURING THE CONVERTED PROCEDURE, THE PHYSICIAN CLAIMED THAT THE "SURGERY TIME TOOK TOO LONG WHICH WAS NOT GOOD," AND "ANESTHESIOLOGY WAS BAD." THEREFORE, IT WAS DETERMINED THAT THE OPERATIVE COMPLICATIONS AND SUBSEQUENT DEATH OCCURRED AFTER THE ROBOT WAS UNDOCKED FROM THE PATIENT, AND WERE UNRELATED TO THE DA VINCI SURGICAL SYSTEM.

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE PATIENT¿S DEMISE IS UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO CONTACT THE SURGEON TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, NO NEW OR ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE SURGEON OR SITE AS OF THE DATE OF THIS REPORT. THE FOLLOWING INFORMATION IS UNKNOWN: THE PATIENT'S MEDICAL HISTORY, WHAT TYPE OF DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED, AND WHAT INTRA-OPERATIVE COMPLICATIONS (IF ANY) THE PATIENT EXPERIENCED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2019. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING: DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, A PATIENT REPORTEDLY EXPIRED. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE PATIENT¿S DEMISE IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE PERFORMED ON (B)(6) 2019, THE PATIENT EXPIRED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077431 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-37

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DA VINCI INSTRUMENTS AND ACCESSORIES| DA VINCI INSTRUMENTS AND ACCESSORIES