BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3092969 · Received May 3, 2013

    Report

    Report Number
    2955842-2013-01545
    Event Type
    Death
    Date Received
    May 3, 2013
    Date of Event
    July 6, 2012
    Report Date
    April 9, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL HAS MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. ON (B)(6) 2013, THE SITE'S RISK MANAGER INDICATED THAT DUE TO (B)(6) REGULATIONS, THE HOSPITAL IS UNABLE TO PROVIDE ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT WITHOUT A SUBPOENA. ON (B)(6) 2013, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) FOR THE HOSPITAL. THE CSR INDICATED THAT SHE WAS NOT THE CSR FOR THE HOSPITAL WHEN THE REPORTED EVENT OCCURRED. APPROXIMATELY TWO MONTHS AGO, A PHYSICIAN AT THE HOSPITAL REPORTED TO HER THAT AN ADVERSE EVENT CONCERNING A DA VINCI GYN PROCEDURE HAD OCCURRED AT THE HOSPITAL. PER THE CSR, THE PHYSICIAN INDICATED TO HER THAT THE PROCEDURE DID NOT GO WELL. NO OTHER DETAILS CONCERNING THE REPORTED EVENT WERE PROVIDED TO THE CSR. THE CSR INDICATED THAT DUE TO HOW LONG AGO THE INCIDENT OCCURRED, IT WAS HER BELIEF THAT THE INCIDENT HAD ALREADY BEEN REPORTED TO ISI. ISI PERFORMED A REVIEW OF THE SITE'S SYSTEM LOG FOR THE REPORTED PROCEDURE DATE. REVIEW OF THE SYSTEM LOGS FOUND THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) WAS PROVIDED WITH THE PATIENT'S DA VINCI SURGERY OPERATIVE (OP) REPORT AND SUPPLEMENTAL HOSPITAL RECORDS FROM THE PLAINTIFF'S ATTORNEY. ACCORDING TO THE INFORMATION IN THE PATIENT'S OP REPORT, THE PATIENT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 DUE TO UTERINE FIBROIDS. ISI'S REVIEW OF THE PATIENT'S OP REPORT FOUND NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2012 THE PATIENT RETURNED TO SURGERY WITH ABDOMINAL PAIN, SWELLING AND SUSPECTED INTESTINAL INJURY FROM RADIOLOGY STUDIES. AN EXPLORATORY LAPAROTOMY WAS PERFORMED WITH THE FINDINGS OF DIFFUSE PERITONITIS AND TWO SMALL BOWEL PERFORATIONS THAT APPEARED TO BE A THROUGH AND THROUGH TYPE INJURY. THE ENTEROTOMIES WERE 2-3MM IN SIZE AND SHOWED NO NECROTIC TISSUE AROUND THEM. THEY WERE REPAIRED PRIMARILY. ON (B)(6) 2012 THE PATIENT UNDERWENT A SECOND EXPLORATORY LAPAROTOMY WITH EXTENSIVE ENTEROLYSIS, ABDOMINAL WASHOUT, AND GASTROTOMY. ON (B)(6) 2012 THE PATIENT UNDERWENT A TRACHEOSTOMY. THE PATIENT'S CARE WAS MANAGED IN THE INTENSIVE CARE UNIT (ICU) BY INFECTIOUS DISEASE, RENAL, SURGERY, AND ICU CONSULTANTS. THE PATIENT DEVELOPED HYPOTENSION ON (B)(6) 2012 AND EXPIRED AFTER CPR FAILED. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, INTUITIVE SURGICAL RECEIVED A LEGAL COMPLAINT ALLEGING THAT A PATIENT WHO UNDERWENT A DA VINCI SI SURGICAL PROCEDURE ON (B)(6) 2012, EXPIRED ON (B)(6) 2012. THE LEGAL COMPLAINT ALLEGES THAT FROM (B)(6) 2012, THE PATIENT REQUIRED CARE AND TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195215 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60.P4

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death DAV SI SURG SYSTEM, INSTRUMENTS AND ACCESSORIES