BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2983513 · Received February 28, 2013

    Report

    Report Number
    2955842-2013-00665
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 29, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL CONTACTED INITIAL REPORTER OF THIS EVENT, SHE INDICATED THAT THE PATIENT CONDITION WAS STABLE; THE PATIENT DIDN'T SUFFER ANY FURTHER COMPLICATIONS. ACCORDING TO THE INFORMATION PROVIDED BY THE SURGICAL STAFF, THE GROUND PADS WERE CORRECTLY POSITIONED ON THE PATIENT. THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) COULD NOT FIND ANY DAVINCI SYSTEMS MALFUNCTIONS. FSE PERFORMED AN ELECTRICAL SAFETY TEST AND SYSTEM VERIFICATION TEST. FSE VERIFIED THAT ELECTRICAL SAFETY PASSED ON THE VISION SITE CART, SURGEON CONSOLE CART, AND PATIENT SITE CART. HE ALSO VERIFIED THAT ALL 3 OF THE CANNULA MOUNTS WERE ELECTRICALLY ISOLATED FROM THE SYSTEM THROUGH THE RESISTANCE CHECKS. THE DAVINCI ROBOTIC COORDINATOR INDICATED THAT ALL ENERGY LEVELS ON THE ELECTRO SURGICAL UNIT (ESU) WERE CONFIRMED TO BE SET AT 45 AND THE PROCEDURE WAS SIDE DOCKED. THE VALLEYLAB GENERATOR (FORCE TRIAD) USED ON THIS PROCEDURE WAS TESTED BY THE CUSTOMER. BIOMED REPORTED THAT VALLEYLAB GENERATOR PASSED ELECTRICAL SAFETY TESTS AND POWER TEST. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT USED ON THIS EVENT WAS RETURNED AND EVALUATED BY ISI, THE INSTRUMENT WAS FOUND TO BE WITHIN SPECIFICATIONS. INVESTIGATION HAS SHOWN THAT IT IS POSSIBLE FOR THE ELECTROSURGICAL UNIT (ESU) CURRENTS TO PASS THROUGH THE PATIENT SIDE MANIPULATOR ARMS TO GROUND, THROUGH THE CANNULA ACCESSORY TO THE PATIENT, IF THE PATIENT IS NOT PROPERLY GROUNDED. HOWEVER, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DEFINITIVELY DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. AS OF (B)(4) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THIS ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER OF A SUCCESSFUL DAVINCI SI HYSTERECTOMY PROCEDURE, WHILE THE SURGICAL STAFF WAS REMOVING THE CANNULA FROM THE PATIENT, IT WAS NOTED THAT THE PATIENT SUSTAINED BURN MARKS ON THE SURFACE OF THE SKIN. THIS MDR WAS CREATED TO ADDRESS THE EVENT OCCURRED ON (B)(6) 2013; REPORTED BY DAVINCI COORDINATOR ON RELATED MDR 2955842-2013-00666.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88097 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60P6

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES