BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2939247 · Received February 1, 2013

    Report

    Report Number
    2955842-2013-00332
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED A TEST DRIVE AT THE CUSTOMER SITE WITH THE ALLEGED PSM ARM, AND OBSERVED NO NON-INTUITIVE OR UNEXPECTED MOTION. A BRAKE TEST ON THE PATIENT SIDE MANIPULATOR (PSM) AND SET-UP JOINT (SUJ) WAS PERFORMED BY THE FSE, AND BOTH PASSED ACCORDING TO ISI STANDARDS. THE FSE EXCHANGED THE PSM AS A PRECAUTION. THE SYSTEM IS WORKING ACCORDING TO ISI SPECIFICATIONS. THE PSM WAS RETURNED AND EVALUATED. ENGINEERING PERFORMED A VISUAL INSPECTION OF THE PSM. THE ARM WAS CONFIGURED TO THE SYSTEM AND IT POWERED UP IN MAINTENANCE MODE. THE CHECK-SENSORS, FRICTION, AND BRAKE TESTS AS WELL AS AN HOUR LONG SINE CYCLE WERE RUN. THE PSM WAS ALSO RESTARTED ON THE IN-HOUSE SYSTEM IN NORMAL MODE. THE ARM WAS DRIVEN WITH AN INSTRUMENT FOR SEVERAL MINUTES IN SEVERAL DIFFERENT POSITIONS. ENGINEERING TRIED BUMPING THE PSM IN SEVERAL SPOTS TO ATTEMPT AND GET IT TO MOVE ON ITS OWN; HOWEVER, THE REPORTED PROBLEM WAS NOT ABLE TO BE RECREATED OR VERIFIED. NO REPAIRS ARE REQUIRED FOR THIS ISSUE. ON (B)(6) 2013, THE REPORTER OF THIS COMPLAINT WAS CONTACTED FOR ADDITIONAL INFORMATION. IT WAS STATED THAT THE PATIENT WAS DOING WELL, AND WAS SEEN FOR A REGULAR CHECK-UP RECENTLY. THE INJURY TO THE ARTERY WAS FIXED BY THE SURGEON AS SOON AS IT WAS DISCOVERED DURING THE PROCEDURE, AND THE SURGERY DID NOT HAVE TO BE CONVERTED AS A RESULT. THE SITE REPORTEDLY DID NOT EXPERIENCE ANY RECURRENCE OF THIS EVENT SINCE THE REPORTED COMPLAINT. THIS WAS THE ONLY TIME THAT THIS HAS HAPPENED WITHOUT THE SURGEON MOVING OR REPOSITIONING/CONTROLLING THE ARM MOVEMENT, ACCORDING TO THE REPORTER. THERE WERE NO MALFUNCTIONS OF THE INSTRUMENTS/ ACCESSORIES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON HAD ARTICULATION ISSUES WITH ONE OF THE PATIENT SIDE MANIPULATORS (PSM). THE STAFF REPORTEDLY RE-SEATED THE INSTRUMENT AND EVENTUALLY REPLACED THE DRAPE ON THAT PSM. HOWEVER, THE ISSUE PERSISTED INTERMITTENTLY. IT WAS STATED THAT THE ARM JUMPED, CAUSING THE INSTRUMENT HELD IN THAT PSM TO STAB AN ARTERY, WHICH LED TO SOME BLEEDING THAT THE SURGEON WAS ABLE TO CONTROL WITHOUT CONVERTING THE PROCEDURE. THE SCHEDULED PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45033 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000- A60P6

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES