BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 4031281 · Received August 22, 2014

    Report

    Report Number
    2955842-2014-05148
    Event Type
    Death
    Date Received
    August 22, 2014
    Date of Event
    January 26, 2012
    Report Date
    July 23, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE LEGAL DOCUMENT PROVIDED 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 ATTEMPTED 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. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(4) 2012. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S OPERATIVE COMPLICATIONS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PROVIDED LEGAL DOCUMENT INDICATES THAT THE PATIENT UNDERWENT A DA VINCI SURGICAL PROCEDURE, SUSTAINED A VESSEL INJURY, AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S OPERATIVE COMPLICATION IS UNKNOWN.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI NISSEN FUNDOPLICATION AND HIATAL HERNIA REPAIR PROCEDURE ON (B)(6) 2012. THE PATIENT REPORTEDLY SUSTAINED A LACERATION TO THE PORTAL VEIN DURING THE SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY ON (B)(6) 2012. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, WHILE THE SURGEON WAS DISSECTING AWAY MESENTERY IN THE AREA OF THE LESSER CURVATURE OF THE STOMACH, SIGNIFICANT BLEEDING WAS ENCOUNTERED AND A LATERAL LACERATION TO THE MEDIAL ASPECT OF THE PORTAL VEIN WAS THEN IDENTIFIED. AFTER RECOGNIZING THE VESSEL INJURY, THE SURGEON MADE THE DECISION TO CONVERT TO AN OPEN PROCEDURE AND ENTERED THE PATIENT'S ABDOMEN THROUGH A VERTICAL MIDLINE INCISION. VASCULAR SURGERY WAS THEN CONTACTED FOR ASSISTANCE. WHILE VASCULAR SURGERY WAS EN ROUTE, THE SURGEON CROSS CLAMPED THE PORTAL VEIN, PROCEEDED WITH THE NISSEN FUNDOPLICATION PROCEDURE, AND COMPLETED THE ORIGINALLY INTENDED PROCEDURE. UPON ARRIVING IN THE OPERATING ROOM, A VASCULAR SURGEON IDENTIFIED A LATERAL LACERATION TO THE MEDIAL ASPECT OF THE PORTAL VEIN AND PLACED TWO VASCULAR CLAMPS AND PERFORMED A LATERAL PORTAL VENORRHAPHY WITH SUTURES. THE VASCULAR SURGEON THEN TURNED THE PATIENT BACK OVER TO ORIGINAL SURGEON WHO HAD PERFORMED THE NISSEN FUNDOPLICATION PROCEDURE. ACCORDING TO THE LEGAL DOCUMENT, PRIOR TO CLOSE, A DISCREPANCY IN THE SUTURE COUNT OCCURRED, REQUIRING AN X-RAY. IN ADDITION, THE ESTIMATED BLOOD LOSS DURING SURGERY WAS 1.6 LITERS AND IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED PROLONGED HYPOTENSION, DEVELOPING ACUTE KIDNEY INJURY AND OLIGOANURIA. DURING THE COURSE OF THE PATIENT'S HOSPITALIZATION AND WHILE AWAITING TRANSFER TO ANOTHER HOSPITAL, THE PATIENT EXPERIENCED SYMPTOMS OF SHOCK CONSISTING OF SYSTEMIC HYPOTENSION, INCREASED RESPIRATORY RATE, DECREASE IN OXYGEN SATURATION, DECREASED URINARY OUTPUT, ACIDOSIS, AND A REDUCED LEVEL OF CONSCIOUSNESS. UPON ADMISSION TO ANOTHER HOSPITAL, THE PATIENT WAS IMMEDIATELY GIVEN SIGNIFICANT AMOUNTS OF BLOOD PRODUCTS. A CT SCAN PERFORMED THE FOLLOWING DAY REVEALED A THROMBOSED PORTAL VEIN. ON (B)(6) 2012, A PORTAL VENOGRAM WAS PERFORMED AND ATTEMPTED WERE MADE TO OPEN UP THE PORTAL VEIN. DUE TO THE PATIENT'S RESPIRATORY STATUS AND DIFFICULTY WITH CANNULATING THE PORTAL VEIN, THE PROCEDURE WAS ABORTED. FROM (B)(6) 2012, THE PATIENT REMAINED ON A VENTILATOR AND HER CONDITION CONTINUED TO DETERIORATE. ON (B)(6) 2012, THE PATIENT PASSED AWAY. THE PATIENT'S AUTOPSY REVEALED THE FOLLOWING: MASSIVE INTRA-PERITONEAL HEMORRHAGE (1500 ML) WITH EXTENSIVE FRESH BLOOD CLOTS; DIFFUSE BILATERAL ALVEOLAR DAMAGE; MASSIVE ISCHEMIC COAGULATION NECROSIS OF THE LIVER; AND SUPERIOR MESENTERIC AND PORTAL VEIN THROMBI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510178 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

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