BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3473424 · Received November 18, 2013

    Report

    Report Number
    2955842-2013-05241
    Event Type
    Death
    Date Received
    November 18, 2013
    Date of Event
    October 15, 2013
    Report Date
    November 18, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, THE SITE CONTACTED ISI TECHNICAL SUPPORT FOR MULTIPLE ERRORS WITH THE PSM 2, ALONG WITH A MESSAGE INDICATING THAT THE FIBER CABLE REQUIRED CLEANING. ON (B)(6) 2013, THE ISI FSE REPLACED THE PSM 2 AND CLEANED THE FIBER CABLES, WHICH CORRECTED THE REPORTED PROBLEM. THE FSE ALSO FOUND A LOOSE PIN ON THE CANNULA MOUNT OF PSM 1. THE SYSTEM WAS TESTED AND VERIFIED TO BE READY FOR USE. SYSTEM LOGS OF THE DA VINCI SYSTEM INDICATED THAT THE SITE PERFORMED A SURGERY ON (B)(6) 2013 WITH NO ISSUES. ISI CONDUCTED ADDITIONAL INVESTIGATION ON THE RETURNED PSM 2. IT WAS NOTED THAT THE PSM 2 FAILED 2 TESTS AND PASSED ALL OTHER TESTS. BASED ON THE PROVIDED INFORMATION, THERE WAS NO ALLEGATION THAT THE DA VINCI SYSTEM CONTRIBUTED TO THE PATIENT'S DEATH. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DIED FOLLOWING A DA VINCI SURGICAL PROCEDURE.

    Additional Manufacturer Narrative · 1

    SUBMITTING FOLLOW-UP MDR1 TO PROVIDE INITIAL REPORTER'S CONTACT INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A PATIENT UNDERWENT A DA VINCI MITRAL VALVE REPAIR PROCEDURE. THE SITE EXPERIENCED SEVERAL FAULTS WITH THE PATIENT SIDE MANIPULATOR ARM (PSM) 2 WITH THE DA VINCI SYSTEM AND CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT. THE FAULTS WERE RECOVERED AND THE SITE COMPLETED THE DA VINCI PROCEDURE. THE SITE WAS INFORMED THAT AN ISI FIELD SERVICE ENGINEER (FSE) WOULD COME OUT TO INSPECT THE DA VINCI SYSTEM. AT AN UNSPECIFIED TIME AFTER THE DA VINCI SYSTEM WAS UNDOCKED FROM THE PATIENT, THE PATIENT SUBSEQUENTLY EXPIRED. ISI DID NOT BECOME AWARE OF THE PATIENT'S DEATH UNTIL THE FOLLOWING DAY WHEN AN ISI FSE VISITED THE SITE TO INSPECT THE DA VINCI SYSTEM. A NURSE AT THE SITE HAD INFORMED THE FSE THAT THE PATIENT DIED AFTER THE DA VINCI SURGICAL PROCEDURE. THE DA VINCI SYSTEM WAS REPAIRED AND VERIFIED TO BE READY FOR USE. ON (B)(6) 2013, THE SURGEON INFORMED AN ISI REPRESENTATIVE THAT THE PATIENT'S DEATH HAD NOTHING TO DO WITH THE DA VINCI SYSTEM BUT THE SURGEON DID NOT PROVIDE ANY FURTHER DETAILS. ON (B)(6) 2013, ISI CLINICAL CONSULTANT SPOKE WITH THE SURGEON INVOLVED WITH THE REPORTED EVENT. THE SURGEON VERIFIED THAT THE PATIENT DIED FOLLOWING A DA VINCI MITRAL VALVE REPLACEMENT OPERATION. THE SURGEON ALSO CONFIRMED THAT THE PATIENT'S OUTCOME HAD NOTHING TO DO WITH THE ROBOTIC PORTION OF THE CASE. THE PATIENT'S DEATH WAS THE RESULT OF OTHER FACTORS IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595511 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000, A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1