BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3628682 · Received February 14, 2014

    Report

    Report Number
    2955842-2014-00892
    Event Type
    Death
    Date Received
    February 14, 2014
    Date of Event
    December 27, 2013
    Report Date
    January 16, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AND SUBSEQUENT PASSED AWAY AFTER UNDERGOING A DA VINCI SI SURGICAL HYSTERECTOMY PROCEDURE, HERNIA REPAIR, AND LAPARATOMY. THE SURGEON REPORTEDLY BELIEVES THAT THE PATIENT'S POST-SURGICAL COMPLICATIONS AND DEATH ARE RELATED TO THE 8MM CANNULA THAT WAS NOT REINSERTED INTO THE SAME CANNULA PORT DURING THE (B)(6) 2013 DA VINCI SURGERY. THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES.

    Description of Event or Problem · 1

    ON (B)(4) 2014, AN INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE BECAME AWARE OF A PATIENT WHO PASSED AWAY 11 DAYS AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE, HERNIA REPAIR, AND LAPARATOMY PROCEDURE. THE FOLLOWING INFORMATION WAS OBTAINED FROM THE SURGEON WHO PERFORMED THE DA VINCI SURGERY. ON (B)(6) 2013, A PATIENT UNDERWENT A DA VINCI HYSTERECTOMY WITH NODES DISSECTION PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY ON (B)(6) 2013. THE PATIENT REPORTEDLY DID NOT SUSTAIN ANY BOWEL INJURIES DURING THE DA VINCI SURGERY. ON (B)(6) 2013, THE SURGEON WHO PERFORMED THE DA VINCI SURGERY PERFORMED A HERNIA REPAIR ON THE PATIENT AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2014 MORNING, THE PATIENT RETURNED TO THE HOSPITAL WITH PAIN. SHE HAD AN UNSPECIFIED CT SCAN (RESULTS WERE NOT PROVIDED) AND AN ARTERIOGRAM (VESSELS WERE NORMAL). THE PATIENT UNDERWENT 2 CT SCANS AND LATER WENT INTO RENAL FAILURE AND BECAME SEPTIC THE SAME DAY. THE PATIENT WAS TAKEN BACK TO SURGERY ON (B)(6) 2014 FOR A LAPAROTOMY, WHICH WAS WHEN THE INCARCERATED DISTAL ILEUM AND CECUM WERE IDENTIFIED. ON (B)(6) 2014 MIDNIGHT, THE PATIENT CODED AND WAS RESUSCITATED. APPROXIMATELY 7:30AM THE SAME DAY, THE PATIENT CODED AND WAS NOT REVIVED. THE SURGEON INDICATED THAT DURING THE (B)(6) 2013 DA VINCI SURGERY, AN 8MM CANNULA ON PATIENT SIDE MANIPULATOR 1 (PSM 1) WAS DISLODGED AND RE-INSERTED BY THE SURGICAL ASSISTANT. THE SURGEON BELIEVES THAT THE REINSERTION OF THE CANNULA CREATED A SECOND FACIAL HOLE CEPHALAD TO THE ORIGINAL DEFECT CREATED BY THE INITIAL CANNULA INSERTION. THE SURGEON CLOSED THE 12MM CAMERA PORT AND 12 MM ASSIST LAPAROSCOPIC PORT; HOWEVER, THE 8MM CANNULA PORTS WERE NOT CLOSED. DURING THE (B)(6) 2013 HERNIA REPAIR, THE SURGEON OPENED THE PATIENT'S LOWER RIGHT QUADRANT 8MM PORT SITE AND EXAMINED THE FACIAL DEFECT DIRECTLY BUT DID NOT SEE VISUALIZE THE SECOND DEFECT THAT WAS 3CM CEPHALAD TO THE ORIGINAL DEFECT. THE SURGEON FELT THAT THE UNIDENTIFIED HERNIA AT THE PORT SITE CAUSED THE INCARCERATED HERNIA, WHICH WAS LATER MISSED DURING THE HERNIA REPAIR. THE PATIENT ULTIMATELY BECAME SEPTIC AND THEN EXPIRED ON (B)(6) 2014. THE SURGEON FELT THAT IF THE SURGICAL ASSIST HAD PLACED THE CANNULA INTO THE ORIGINAL HOLE DURING THE (B)(6) 2013 DA VINCI SURGERY, THE PATIENT'S POST-SURGICAL COMPLICATIONS AND DEATH COULD HAVE BEEN AVOIDED. THERE WAS NO ALLEGATION OF A MALFUNCTION WITH THE DA VINCI SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97849 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000, A.60P8

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| H| L| R