BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3968400 · Received July 30, 2014

    Report

    Report Number
    2955842-2014-04622
    Event Type
    Death
    Date Received
    July 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 09/08/2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER INDICATED THAT THE PATIENT UNDERWENT THE DA VINCI HERNIA REPAIR PROCEDURE ON (B)(6) 2014. THE PATIENT WAS A (B)(6) MALE WITH A RIGHT INGUINAL HERNIA AND UMBILICAL INCISIONAL HERNIA. THE PATIENT TOLERATED THE DA VINCI SURGICAL PROCEDURE WELL AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS REPORTED. ACCORDING TO THE RISK MANAGER, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON AN UNSPECIFIED DATE AFTER COMPLETION OF THE DA VINCI SURGICAL PROCEDURE. ON (B)(6) 2014, THE PATIENT PRESENTED TO ANOTHER MEDICAL CENTER WITH COMPLAINTS OF INCREASED PAIN IN THE SURGICAL AREA AND INTERMITTENT DIZZINESS. THE PATIENT WAS ADMITTED IN THE SURGICAL ICU FOR A RIGHT RETROPERITONEAL HEMATOMA WITH ACTIVE EXTRAVASATION. ON (B)(6) 2014, THE PATIENT PASSED AWAY. THE RISK MANAGER WAS UNABLE TO PROVIDE THE CAUSE OF THE PATIENT'S DEATH. THE RISK MANAGER ALSO INDICATED THAT THE PATIENT'S AUTOPSY REPORT AND DEATH CERTIFICATE WERE NOT AVAILABLE FOR ISI TO REVIEW.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE PATIENT'S DEATH. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. THE DATE OF THE DA VINCI SURGICAL PROCEDURE, THE NAME OF THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE, AND THE DATE OF THE PATIENT'S DEATH ARE UNKNOWN. ISI HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SITE 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: THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT A PATIENT PASSED AWAY AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN IF THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI INCISIONAL HERNIA REPAIR PROCEDURE, THE PATIENT PASSED AWAY. THE INITIAL REPORTER OF THIS COMPLAINT, A RESIDENT, DID NOT KNOW THE DATE OF THE DA VINCI SURGICAL PROCEDURE AND WHAT DATE THE PATIENT PASSED AWAY. THE INITIAL REPORTER EXPLAINED THAT HE WAS INFORMED OF THE PATIENT DEATH BY ANOTHER RESIDENT. THE INITIAL REPORTER DID NOT HAVE THE RESIDENT'S CONTACT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445084 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death