BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3276053 · Received August 9, 2013

    Report

    Report Number
    2955842-2013-03004
    Event Type
    Death
    Date Received
    August 9, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 11, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON AUGUST 14, 2013, INTUITIVE SURGICAL, INC. CONTACTED THE HOSPITAL'S RISK MANAGER TO GATHER ADDITIONAL INFORMATION. THE RISK MANAGER INDICATED THAT THERE WAS NO AUTOPSY PERFORMED ON THE PATIENT, AS THE FAMILY DECLINED TO HAVE ONE PERFORMED. HE ALSO INDICATED THAT HE WAS NOT AT LIBERTY TO PROVIDE ANY OTHER DETAILS REGARDING THE REPORTED EVENT DUE TO HIPAA REGULATIONS.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO DUPLICATE THE ISSUE EXPERIENCED BY THE SITE. FUNCTIONAL TESTING OF THE SYSTEM FOUND THAT THE SYSTEM FUNCTIONED WITHIN SPECIFICATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A PATIENT DEATH OCCURRED DURING A DA VINCI SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, IT HAS BEEN DETERMINED THAT THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEMISE; BUT RATHER THE PATIENT'S CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI THORACIC PROCEDURE, THE PATIENT EXPIRED. REPORTEDLY, PRIOR TO THE PATIENT'S DEMISE, WHILE THE SURGEON WAS MANIPULATING THE MASTER TOOL MANIPULATORS (MTMS) ON THE SURGEON SIDE CONSOLE, THE SURGEON WAS UNABLE TO CONTROL OR MOVE THE INSTRUMENT INSTALLED ON A PATIENT SIDE MANIPULATOR (PSM) ARM 1. REPORTEDLY, THE SITE OBSERVED THAT THE LED ON PSM 1 WAS SOLID BLUE IN COLOR WHEN THE ISSUE OCCURRED AND THEY WERE EVENTUALLY ABLE TO RESOLVE THE ISSUE. ON (B)(6) 2013, INTUITIVE SURGICAL CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT THE PATIENT'S DEMISE WAS UNRELATED TO HIS INABILITY TO MANIPULATE THE INSTRUMENT INSTALLED ON PSM 1, BUT RATHER THE PATIENT'S CONDITION. THE PATIENT WAS VERY SICK AND WAS NOT DOING VERY WELL UNDER ANESTHESIA. THE SURGEON INDICATED THAT HE HAD INTENDED TO PERFORM LUNG DECORT USING THE DA VINCI SURGICAL SYSTEM; HOWEVER, AFTER THE SYSTEM WAS DOCKED TO THE PATIENT AND WHEN HE SAT DOWN AT THE SSC, HE WAS UNABLE TO MOVE THE INSTRUMENT THAT WAS INSTALLED ON THE PSM. THE PATIENT HAD CHEST ADHESIONS AND AS A RESULT HE HAD TO CREATE LARGER PORT SITE INCISIONS. HE DID NOT OBSERVE ANY RESTRICTIONS AROUND THE PORT SITES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ISSUE THAT HE EXPERIENCED. THE SURGEON INDICATED THAT THE PATIENT HAD SEVERE VENA CAVA OBSTRUCTION AND WAS A DIALYSIS PATIENT. THE SURGEON INDICATED DUE TO THE PATIENT'S VENOUS BLOCKAGE THE PATIENT WAS BLEEDING FROM HIS PORT SITE INCISIONS AND DURING THE TIME THAT THE ISSUE OCCURRED, THE PATIENT BEGAN TO CODE. THE SYSTEM WAS IMMEDIATELY UNDOCKED FROM THE PATIENT AND RESUSCITATION WAS PERFORMED ON THE PATIENT FOR 45 MINUTES TO 1 HOUR WITHOUT SUCCESS. ON (B)(6) 2013, THE SITE'S DA VINCI COORDINATOR PROVIDED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE DA VINCI COORDINATOR INDICATED THAT THE CANNULAE USED DURING THE SURGICAL PROCEDURE WERE INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE FOUND. A POST-OP INSPECTION OF THE CANNULAE WAS ALSO PERFORMED AND THERE WAS NO DAMAGE TO THE CANNULAE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378983 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR DA VINCI SI SURG. SYS. INSTRUMENTS & ACCESS.