BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4182359 · Received October 17, 2014

    Report

    Report Number
    2955842-2014-05505
    Event Type
    Death
    Date Received
    October 17, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 19, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 AND HIS SUBSEQUENT DEMISE. THERE IS NO ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. 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)(6) 2014. THE SYSTEM LOGS SHOW MULTIPLE SYSTEM ERROR CODE 32003 MESSAGES. A SYSTEM ERROR CODE 32003 SIGNIFIES THAT THE VESSEL SEALER INSTRUMENT WAS NOT ABLE TO DRIVE THE CUTTING BLADE ACROSS THE FULL RANGE OF TRAVEL DURING A CUT COMMAND. THIS COULD BE CAUSED BY A DIRTY VESSEL SEALER INSTRUMENT OR ATTEMPTING TO CUT VERY THICK AND/OR UNSEALED TISSUE. A SYSTEM ERROR CODE 32003 IS AN ENGINEERING ADVISORY ONLY AND DOES NOT INDICATE ANY SYSTEM MALFUNCTION. NO RELATED SYSTEM ERROR CODES INVOLVING AN ENDOWRIST STAPLER INSTRUMENT WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI RIGHT HEMICOLECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 7. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI RIGHT HEMICOLECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 7. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE PATIENT BEGAN TO REFUSE HIS MEDICATIONS AND HAD PULLED OUT HIS NG TUBE PRIOR TO PASSING AWAY. SHE ALSO INDICATED THAT POSSIBLY THE PATIENT ASPIRATED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, HE WAS PRESENT DURING PARTS OF THE DA VINCI SURGICAL PROCEDURE. DURING THE TIMES THAT HE WAS PRESENT, THE CSR INDICATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED. THE CSR STATED THAT AN INITIAL AUTOPSY WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE DEVELOPED ILEUS. IN ADDITION, THE PATIENT'S STAPLE LINE HAD RUPTURED. ON (B)(4) 2014, ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT AND DID NOT FIND ANY REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED. THE RISK MANAGER STATED THAT BASED ON THE OPERATIVE REPORT AND THE SITE'S PRELIMINARY INVESTIGATION, THE DA VINCI SURGICAL SYSTEM WAS NON-CONTRIBUTORY TO THE PATIENT'S DEATH. THE RISK MANAGER ALSO INDICATED THAT AN AUTOPSY HAS BEEN PERFORMED BUT FINAL ANATOMIC DIAGNOSIS IS PENDING MICROSCOPIC EXAMINATION OF TISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662039 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Death