BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 4775681 · Received May 15, 2015

    Report

    Report Number
    2955842-2015-00750
    Event Type
    Death
    Date Received
    May 15, 2015
    Report Date
    May 7, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE OPERATIVE COMPLICATIONS EXPERIENCED BY THE 3 PATIENTS AND THEIR SUBSEQUENT DEMISES. THE FOLLOWING INFORMATION IS UNKNOWN: THE HOSPITAL NAME(S) WHERE EACH ROBOTIC-ASSISTED RADICAL CYSTECTOMY (RARC) WAS PERFORMED, THE NAME(S) OF THE SURGEON(S) WHO PERFORMED EACH RARC, THE DATE OF EACH PATIENT DEATH, THE CAUSE OF EACH PATIENT DEATH, AND WHAT COMPLICATIONS EACH PATIENT EXPERIENCED. THERE IS NO CLAIM WITHIN THE ARTICLE THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, AND/OR AN ACCESSORY OCCURRED DURING THE 3 RARC PROCEDURES. ISI HAS ATTEMPTED TO CONTACT A CORRESPONDENT AUTHOR FROM THE JOURNAL ARTICLE 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: ACCORDING TO THE JOURNAL ARTICLE, 3 PATIENTS EXPERIENCED UNSPECIFIED MAJOR COMPLICATIONS AND SUBSEQUENTLY PASSED AWAY AFTER UNDERGOING A DA VINCI RADICAL CYSTECTOMY PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF EACH PATIENT DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE ARCHIVIO ITALIANO DI UROLOGIA E ANDROLOGIA (2015; 87, 1) JOURNAL ARTICLE TITLED, COMPARING ROBOTIC, LAPAROSCOPIC AND OPEN CYSTECTOMY: A SYSTEMATIC REVIEW AND META-ANALYSIS. (THOMAS FONSEKA ET AL., 2015). WITHIN THE ARTICLE, A STATEMENT IS NOTED ALLEGING THAT 3 PATIENTS REPORTEDLY EXPERIENCED MAJOR COMPLICATIONS AFTER UNDERGOING A DA VINCI® RADICAL CYSTECTOMY PROCEDURE AND SUBSEQUENTLY PASSED AWAY. IN THE STUDY CHARACTERISTICS SECTION, THE FOLLOWING IS STATED, 8.51% OF PATIENTS UNDERGOING RARC HAD MAJOR COMPLICATIONS WITH 3 DEATHS (0.412%) WITHIN 90 DAYS POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319042 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death