BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI X

    MDR report key: 9872146 · Received March 24, 2020

    Report

    Report Number
    2955842-2020-10211
    Event Type
    Death
    Date Received
    March 24, 2020
    Date of Event
    February 21, 2020
    Report Date
    February 24, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K171294
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSES OF THE PATIENT¿S DEMISE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. SYSTEM LOG: THERE WERE TWO HYSTERECTOMY PROCEDURES ON THE SAME DAY BY THE SAME SURGEON, ISI HAS INSUFFICIENT INFORMATION TO IDENTIFY THE PROCEDURE WITH THIS REPORTED INCIDENT. HOWEVER; A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED FOR BOTH HYSTERECTOMY PROCEDURES BY THE SAME SURGEON WITH A PROCEDURE DATE OF (B)(6) 2020. THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS FOR EITHER PROCEDURE THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS FOR BOTH ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. ALL INSTRUMENTS FROM BOTH PROCEDURES WERE USED IN SUBSEQUENT PROCEDURES, WITH THE EXCEPTION OF THE MEGA NEEDLE DRIVER INSTRUMENT(S), AND THE SINGLE USE INSTRUMENTS LIKE THE VESSEL SEALER EXTEND INSTRUMENT(S); HOWEVER, IT IS CONFIRMED THERE ARE NO COMPLAINTS ALLEGED AGAINST THESE INSTRUMENTS. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE THE PATIENT SUBSEQUENTLY EXPIRED ON AN UNSPECIFIED DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE THE PATIENT SUBSEQUENTLY EXPIRED ON AN UNSPECIFIED DATE. ON 03/20/2020, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S NURSE MANAGER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SITE'S NURSE MANAGER STATED HE WAS DIRECTED BY THEIR RISK MANAGEMENT NOT TO PROVIDE ANY INFORMATION. ADDITIONALLY, HE WAS NOT WILLING TO GIVE ANY CONTACT FOR THE RISK MANAGEMENT DEPARTMENT. ISI ALSO CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND SHE PROVIDED THE FOLLOWING INFORMATION: THE CSR STATED THE INFORMATION SHE HAS WAS FROM THE POST-OPERATIVE NURSE WHO INFORMED HER OF THE PATIENT'S DEATH. IT WAS REPORTED THAT THE PATIENT CAME IN FROM THEIR SISTER HOSPITAL SINCE THEY HAD LOST THEIR GYNECOLOGIST AND THE PATIENTS HAD AN OPTION OF GETTING THEIR SURGERIES AT OTHER SISTER HOSPITALS. THIS PATIENT OPTED TO HAVE HER PROCEDURE AT THIS SITE ON (B)(6) 2020. POST-OPERATIVE RECOVERY WAS REPORTED TO BE WELL AND SHE WAS DISCHARGED (ON AN UNSPECIFIED DAY). HOWEVER, POST-OPERATIVE DAY #3 ((B)(6) 2020) WHEN THE POST-OPERATIVE NURSE TRIED TO FOLLOW- UP TO CHECK ON THE PATIENT, HER HUSBAND HAD STATED THAT THE PATIENT HAD TO GO IN TO AN ER IN ANOTHER HOSPITAL AND SHE HAD EXPIRED. THERE WAS NO INFORMATION PROVIDED ON THE DATE OF DEATH, OR CAUSE OF DEATH. THE CSR STATED MAYBE THE SURGEON CAN PROVIDE DETAILS OF THE PROCEDURE. ISI ATTEMPTED TO CONTACT THE SURGEON; HOWEVER, THERE WAS NO RESPONSE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337768 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-37

    Patients

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