BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3872135 · Received June 13, 2014

    Report

    Report Number
    2955842-2014-03634
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 14, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT HAS BEEN DETERMINED THAT THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT WERE NOT CAUSED BY THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES, BUT LIKELY OCCURRED AS A RESULT OF THE PATIENT UNDERGOING A SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: POST A DA VINCI MYOMECTOMY PROCEDURE, THE PATIENT DEVELOPED DEEP VEIN THROMBOSIS AND A PULMONARY EMBOLISM. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES CAUSED THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A DA VINCI MYOMECTOMY PROCEDURE PERFORMED ON (B)(6) 2014, THE PATIENT WAS RE-ADMITTED INTO THE HOSPITAL DUE TO DEEP VEIN THROMBOSIS (DVT) AND A PULMONARY EMBOLISM. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR SHE WAS NOT PRESENT DURING THE PATIENT'S ROBOTIC PROCEDURE; HOWEVER, ANOTHER ISI CSR WAS PRESENT AND ACCORDING TO THAT CSR, NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THE REPORTING CSR INDICATED THAT SHE SPOKE TO THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, THE PATIENT'S DA VINCI MYOMECTOMY PROCEDURE WAS COMPLETED AND TOOK 3 HOURS. THE SURGEON STRUGGLED TO LOCATE THE PATIENT'S MYOMA DUE TO INACCURATE MRI RESULTS, CAUSING THE SURGEON TO CREATE THE HYSTEROTOMY IN AN AREA THAT WAS NOT IDEAL FOR ACCESSING THE PATIENT'S MYOMA, WHICH RESULTED IN A DELAY DURING THE SURGICAL PROCEDURE. THERE WAS A PROCTOR IN THE OR DURING THE SURGICAL PROCEDURE TO ASSIST WITH THE INTERPRETATION OF THE MRI. THE CSR WAS TOLD BY THE SURGEON THAT THE DA VINCI SURGICAL SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE DVT AND EMBOLISM THAT THE PATIENT DEVELOPED. PER THE SURGEON, THE DVT AND PULMONARY EMBOLISM THAT THE PATIENT DEVELOPED WERE COMPLICATIONS THAT CAN OCCUR AS RESULT OF UNDERGOING A SURGICAL PROCEDURE. ON (B)(4) 2014, ISI'S MEDICAL ADVISOR ALSO SPOKE TO THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE INFORMATION PROVIDED BY THE SURGEON, THE PATIENT'S BMI WAS (B)(6) AND SHE MAY HAVE HAD INCIPIENT DIABETES. THE SURGEON LEARNED LATER UPON QUESTIONING THAT THE PATIENT HAD A FAMILY HISTORY OF DVT. THE PATIENT WAS NOT UNDERGOING HORMONE THERAPY AND THE SURGEON DID NOT RECALL IF THE PATIENT HAD ANY UNDERLYING HYPERCOAGULABLE DISORDERS. THE PATIENT DEVELOPED A SMALL PULMONARY EMBOLISM AND WAS TREATED WITH ANTI-COAGULANTS FOLLOWED BY LONG TERM COUMADIN THERAPY. THE SURGEON INDICATED THAT THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND WAS DOING WELL. ACCORDING TO THE SURGEON, IT WAS HIS BELIEF THAT THE DA VINCI MYOMECTOMY PROCEDURE WENT WELL OVERALL. THE PATIENT'S FIBROIDS WERE NOT EASILY REMOVED, CAUSING THE PROCEDURE TO GO LONGER THAN HE HAD ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349349 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention