BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1880162 · Received October 22, 2010

    Report

    Report Number
    2955842-2010-00452
    Event Type
    Death
    Date Received
    October 22, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 22, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE HOSPITAL HAS INDICATED THAT THE PATIENT DEATH WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM WORKED AS INTENDED AND NO SYSTEM MALFUNCTIONS OCCURRED. AS OF OCTOBER 19, 2010, NO SIMILAR INSTANCES OF THIS EVENT HAVE BEEN REPORTED TO INTUITIVE SURGICAL. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S GASTRECTOMY PROCEDURE PERFORMED ON (B)(6) 2010, THE SURGEON NOTICED THAT THE PATIENT'S PANCREAS WAS DAMAGED. THE SURGEON REPAIRED THE DAMAGED PANCREAS AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO SYSTEM MALFUNCTIONS. POST-OPERATIVELY, THERE WAS OCCLUSION OF THE PATIENT'S SUPERIOR MESENTERIC ARTERY AND NECROSIS OF THE COLON OCCURRED. ON (B)(6) 2010, THE PATIENT UNDERWENT ANOTHER SURGICAL PROCEDURE TO RESECT HIS BOWEL. NECROTIZING FASCIITIS OCCURRED AFTER THE SURGERY AND THE PATIENT PASSED AWAY ON (B)(6) 2010, DUE TO MULTI-ORGAN FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S GASTRECTOMY PROCEDURE PERFORMED ON (B)(6) 2010, THE SURGEON NOTICED THAT THE PATIENT'S PANCREAS WAS DAMAGED. THE SURGEON REPAIRED THE DAMAGED PANCREAS AND A DRAIN WAS PLACED AROUND THE PANCREAS. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO SYSTEM MALFUNCTIONS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH PANCREATIC FISTULA AND HIS BLOOD HEPATIC ENZYME LEVEL WAS HIGH. ON THE EVENING OF (B)(6) 2010, A CT SCAN WAS PERFORMED AND IT WAS DISCOVERED THAT THE UPPER INTESTINAL MEMBRANE ARTERY WAS BLOCKED AND BOWEL ISCHEMIA WAS FOUND AROUND THE PERFUSED AREA OF THE UPPER INTESTINAL MEMBRANE ARTERY. THE PATIENT UNDERWENT ANOTHER SURGICAL PROCEDURE AND A DRAIN WAS AGAIN PLACED AROUND THE PANCREAS. A GASTROSTOMY TUBE AND DUODENAL FISTULA TUBE WERE ALSO PLACED. WHILE IN ICU, THE PATIENT'S METABOLIC ACIDOSIS DID NOT IMPROVE AND HIS BOWEL COLOR WAS GETTING WORSE. ON (B)(6) 2010, THE PATIENT'S ABDOMEN WAS RE-OPENED AND HIS 4M SMALL BOWEL AND RIGHT COLON WERE RESECTED. NECROTIZING FASCIITIS OCCURRED AFTER THE SURGERY. THE BLOOD POISONING COULD NOT BE CONTROLLED AND THE PATIENT PASSED AWAY ON (B)(6) 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DA VINCI S SYSTEM INSTRUMENTS & ACCESSORIES