BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3773433 · Received April 25, 2014

    Report

    Report Number
    2955842-2014-02551
    Event Type
    Death
    Date Received
    April 25, 2014
    Date of Event
    January 18, 2013
    Report Date
    March 31, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2013. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT DEVELOPED A PELVIC ABSCESS AND SEPTIC SHOCK, AND SUBSEQUENTLY PASSED AWAY APPROXIMATELY 6 WEEKS AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S PELVIC ABSCESS IS UNKNOWN.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY FOR FIBROIDS ON (B)(6) 2013. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND SUPPLEMENTAL HOSPITAL MEDICAL RECORDS. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON NOTED THAT THERE WAS SOME DIFFICULTY PLACING TROCARS DUE TO DENSE INTRA-ABDOMINAL ADHESIONS. PERTINENT FINDINGS INCLUDED ADHESIONS OF THE BOWEL AND OMENTUM TO THE ANTERIOR ABDOMINAL WALL. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR AN ACCESSORY DURING THE OPERATION. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. AFTER THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT PRESENTED WITH THE FOLLOWING: ON (B)(6) 2013 THE PATIENT PRESENTED WITH LEAKING FLUID FROM HER VAGINA. A CYSTOSCOPY WAS PERFORMED WITH BILATERAL RETROGRADE PYELOGRAPHY. NO URINARY INJURY WAS DETECTED. A DIAGNOSTIC LAPAROSCOPY WAS INITIATED BUT THEN ABANDONED DUE TO ADHESIONS. ON (B)(6) 2013, AN EXPLORATORY LAPAROTOMY WAS THEN PERFORMED. THE BOWEL WAS FOUND TO BE DENSELY ADHERENT TO THE UPPER ANTERIOR ABDOMINAL WALL. PELVIC ABSCESSES WERE IDENTIFIED AND DRAINED PARTIALLY THROUGH THE VAGINAL CUFF. NO BOWEL INJURIES WERE NOTED. POST-LAPAROTOMY THE PATIENT DEVELOPED SEPTIC SHOCK, ACUTE RENAL FAILURE, METABOLIC ACIDOSIS, AND ANEMIA. BLOOD TRANSFUSIONS AND ANTIBIOTICS WERE REQUIRED. WHILE IN THE ICU, THE PATIENT DEVELOPED CHF. THE PATIENT WAS TREATED WITH PRESSORS BUT CONTINUED TO DECLINE. THE PATIENT WAS EXTUBATED ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT BECAME LESS RESPONSIVE, EXPERIENCED RESPIRATORY DISTRESS AND A SEIZURE, WAS RE-INTUBATED, AND DEVELOPED PNEUMONIA AND BOWEL OBSTRUCTION. THE PATIENT'S CONDITION HAD A GRADUAL DECLINE WHICH CONTINUED WITH DIMINISHED MENTAL STATUS. NEUROLOGICAL STUDIES SHOWED POOR PROGNOSIS. THE PATIENT WAS PRONOUNCED DEAD ON (B)(6) 2013 AFTER RESUSCITATIVE MEASURES WERE WITHDRAWN. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER INDICATED THAT THE SITE REVIEWED THE PATIENT'S MEDICAL RECORDS AND THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250995 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| H| L| R