BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 6012048 · Received October 7, 2016

    Report

    Report Number
    2955842-2016-00715
    Event Type
    Death
    Date Received
    October 7, 2016
    Date of Event
    August 10, 2016
    Report Date
    September 7, 2016
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE ALLEGED OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. 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 ALLEGED THAT THE PATIENT SUSTAINED 3 BOWEL PERFORATIONS WHILE UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, DEVELOPED POST-OPERATIVE SEPSIS, AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S ALLEGED OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE ARE UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5064171 WITH THE FOLLOWING EVENT DESCRIPTION: PT WAS MY SISTER (B)(6), DOB (B)(6) 1957, WHO HAD ELECTIVE SURGERY ON (B)(6) 2016 FOR A PARTIAL HYSTERECTOMY. THE SURGERY PERFORMED AT (B)(6) HOSPITAL IN (B)(6), WITH A DA VINCI ROBOT. DURING THE PROCEDURE, HER BOWEL WAS PERFORATED THREE TIMES. THIS WAS UNDETECTED BY THE SURGEON OR THE MEDICAL STAFF. SHE WAS KEPT OVERNIGHT FOR OBSERVATION DUE TO PAIN ON (B)(6) 2016 AND DISCHARGED ON (B)(6) AND DISCHARGED ON (B)(6) 2016. SHE LIVED ALONE AND WAS IN TOUCH FOR A WHILE WITH DISTANT RELATIVES. WHEN NOT HEARD FROM ON (B)(6) 2014 A FRIEND WAS CALLED TO DO A WELFARE CHECK ON HER. SHE WAS FOUND UNCONSCIOUS, BLUE IN COLOR, DELIRIOUS AND IN SEVERE RESPIRATORY DISTRESS FROM SEPTIC SHOCK. SHE WAS TRANSPORTED VIA AMBULANCE TO (B)(6) HOSPITAL IN (B)(6) WHERE SHE WAS DIAGNOSED WITH SEPTIC SHOCK AND PLACED INTO EMERGENCY SURGERY. SHE DIED AT APPROX. 9:45 PM ON SUNDAY (B)(6) 2016. THE (B)(6) MEDICAL EXAMINER REPORT STATES THE CAUSE OF DEATH WAS SEPTIC SHOCK FROM THREE PERFORATIONS OF THE BOWEL. THIS PROBLEM FROM MY RESEARCH HAPPENS IN LESS THAN 1/2 OF ONE PERCENT OF CASES THAT ARE DONE WITH NORMAL LAPAROSCOPIC SURGERY WITH NO ROBOT. IT IS MY UNDERSTANDING THAT IT HAPPENS A LOT MORE OFTEN WITH THE DA VINCI ROBOT AND IS UNDER REPORTED! THIS NEEDS TO BE INVESTIGATED ASAP AND IT REPRESENTS AN IMMEDIATE DANGER TO THE PUBLIC AT LARGE! MY SISTER HAS NO CHILDREN BUT SHE DID HAVE FAMILY WHO LOVED HER AND MANY STUDENTS WHO SHE TAUGHT WHO LOVED HER. THIS SHOULD NOT HAVE HAPPENED TO HER AND THE FDA NEEDS TO TAKE IMMEDIATE ACTION TO PRESENT [SIC] IT FROM HAPPENING TO SOMEONE ELSE. ON (B)(6) 2016, ISI CONTACTED THE INITIAL REPORTER OF FDA VOLUNTARY REPORT MW5064171 AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: AFTER THE EVENT OCCURRED, THE INITIAL REPORTER SPOKE TO TWO DIFFERENT SURGEONS FROM THE SITE. THE INITIAL REPORTER STATED THAT THE SURGEONS DID NOT REPORT ANYTHING UNUSUAL REGARDING THE SURGICAL PROCEDURE ALTHOUGH THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. THE INITIAL REPORTER WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT OTHER THAN THE NAME OF ONE OF THE TWO SURGEONS HE SPOKE TO AND THE PHONE OF THE HOSPITAL'S OB/GYN OFFICE. ON (B)(4) 2016, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR). THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. HE WAS INFORMED ABOUT THE EVENT A WEEK EARLIER FROM THE SITE'S ROBOTICS COORDINATOR. ACCORDING TO THE CSR, THE ROBOTICS COORDINATOR INFORMED HIM THAT THE PATIENT HAD PASSED AWAY POST-OPERATIVELY DUE TO A BOWEL INJURY. DURING HIS CONVERSATION WITH THE ROBOTICS COORDINATOR, AN UNIDENTIFIED HOSPITAL EMPLOYEE MENTIONED TO THE CSR THAT THE BOWEL INJURY POSSIBLY OCCURRED DURING PORT PLACEMENT. ISI HAS ATTEMPTED TO CONTACT THE SITE TO FIND THE CAUSE OF THE ALLEGED OPERATIVE INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662484 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R