BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 7853306 · Received September 6, 2018

    Report

    Report Number
    2955842-2018-10511
    Event Type
    Death
    Date Received
    September 6, 2018
    Date of Event
    July 5, 2018
    Report Date
    August 14, 2018
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE ALLEGED POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND THE PATIENT¿S SUBSEQUENT DEMISE. ISI HAS MADE SEVERAL ATTEMPTS TO CONTACT THE OR DIRECTOR AND THE SURGEON TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2018. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE BASED ON THE AVAILABLE SYSTEM LOGS. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT DEVELOPED UNSPECIFIED BOWEL COMPLICATIONS AND SUBSEQUENTLY EXPIRED. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE PATIENT¿S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE ON (B)(6) 2018, THE PATIENT EXPERIENCED UNSPECIFIED POST-OPERATIVE BOWEL COMPLICATIONS. HOWEVER, THE TYPE AND SEVERITY OF THE BOWEL COMPLICATIONS EXPERIENCED BY THE PATIENT ARE UNKNOWN. IT IS ALSO UNKNOWN IF THE PATIENT RECEIVED ANY MEDICAL INTERVENTION OR REQUIRED HOSPITALIZATION DUE TO THE POST-OPERATIVE BOWEL COMPLICATIONS. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT EXPIRED. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE PATIENT¿S POST-OPERATIVE BOWEL COMPLICATIONS AND SUBSEQUENT DEATH ARE UNKNOWN. ON (B)(6) 2018, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES ASSOCIATE (CSA) WHO WAS INFORMED OF THE REPORTED EVENT BY THE SITE¿S OR DIRECTOR AND THE SURGEON. THE CSA WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. THERE WAS ALSO NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691006 DAVINCI XI DA VINCI XI SURGICAL SYSTEM NAY INTUITIVE SURGICAL, INC IS4000 A70P7B

    Patients

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