BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 1727307 · Received June 17, 2010

    Report

    Report Number
    2955842-2010-00265
    Event Type
    Death
    Date Received
    June 17, 2010
    Date of Event
    May 13, 2010
    Report Date
    May 18, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B) (6) 2010, THE CONSOLE SURGEON PERFORMING THE PROCEDURE ADVISED THAT THE SYSTEM PERFORMED AS INTENDED WITH NO ISSUES AND THAT THE PATIENT'S DEATH WAS NOT RELATED IN ANY WAY TO THE DA VINCI SI SURGICAL SYSTEM. THE SURGEON WENT ON TO STATE THAT THE PATIENT HAD A KNOWN PRE-EXISTING CONDITION THAT WAS DIRECTLY RELATED TO THIS EVENT; HOWEVER, THE EXACT CONDITION WAS NOT DISCLOSED TO ISI. HE ALSO MENTIONED THE PATIENT HAD SUFFERED A HEART ATTACK DURING A PREVIOUS SURGICAL PROCEDURE PERFORMED SEVERAL YEARS AGO AND THE RISKS FOR THIS COLON RESECTION WERE KNOWN IN ADVANCE.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE HAS BEEN REMOVED PER FDA REQUEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE ROBOTIC PORTION OF A COLON RESECTION WAS SUCCESSFULLY PERFORMED, THE PATIENT SUFFERED A HEART ATTACK WHILE THE SURGEONS WERE CLOSING THE PATIENT USING STANDARD MEDICAL PROCEDURE. THE PATIENT WAS UNABLE TO BE RESUSCITATED AND EXPIRED ON THE TABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT DELIVER A DOSE WHEN THE PT PENDANT WAS PRESSED. THE PUMP WAS RETURNED TO THE BIOMEDICAL DEPT FROM THE INPATIENT SURGERY UNIT WITH AN UNSIGNED NOTE THAT STATED, "PT CABLE NOT WORKING." NO SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE PROVIDED. DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT DELIVER A DOSE WHEN THE PT PENDANT WAS PRESSED. THE CUSTOMER CONTACT REPORTED THAT WHEN THE DEVICE WAS RETESTED USING A KNOWN GOOD PT PENDANT, THE DEVICE DELIVERED A DOSE WHEN THE PT PENDANT WAS PRESSED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE PUMP WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P3

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES, ESU