BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 3103295 · Received May 9, 2013

    Report

    Report Number
    2955842-2013-01574
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING EVALUATION WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE. A VISUAL INSPECTION OF THE INSTRUMENT SHOWED NO DAMAGE TO THE CONDUCTOR WIRE AND THERE WAS NO PRESENCE OF CHAR MARKS ON ANY OF THE DISTAL END COMPONENTS. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. ENGINEERING ALSO PERFORMED A FUNCTIONAL CAUTERY TEST WITH THE INSTRUMENT USING AN IN-HOUSE GENERATOR AND MONOPOLAR CORD. ENGINEERING FOUND THAT THE INSTRUMENT WAS ABLE TO TRANSFER ENERGY TO A WET TOWEL IN BOTH CUT AND COAG CAUTERY MODES. THE INSTRUMENT WAS DRIVEN ON AN IN-HOUSE IS3000 SYSTEM AND THE INSTRUMENT WAS FOUND TO MOVE INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. NO PHYSICAL DAMAGE WAS FOUND. INTUITIVE SURGICAL HAS MADE SEVERAL ATTEMPTS TO CONTACT THE INITIAL REPORTER OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PERMANENT CAUTERY SPATULA INSTRUMENT AND CANNULA WERE INSPECTED PRIOR TO THE SURGICAL PROCEDURE AND NO ISSUES WERE OBSERVED. THE CANNULA WAS INSPECTED WITH A PIN GAGE. ARCING WAS OBSERVED BY THE SURGICAL STAFF DURING A LEFT UPPER LOBECTOMY PROCEDURE. ACCORDING TO THE SURGICAL STAFF, THE ELECTRICAL ENERGY ARCED TO THE UPPER LEAF PARENCHYMA. THE DETAILS OF THE BURNED TISSUE WERE NOT PROVIDED. THE PATIENT DID NOT RECEIVE ANY TREATMENT OR REQUIRE INTERVENTION DUE TO SUSTAINING THE TISSUE BURN. THE ARCING EVENT WAS OBSERVED APPROXIMATELY 10 SECONDS AFTER THE OPERATION STARTED AND AT THAT TIME, A FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS IN USE. A REVIEW OF THE SURGICAL PROCEDURE ON A RECORDED VIDEO DID NOT SHOW ANY EVIDENCE OF INSTRUMENT COLLISIONS. THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS NOT REMOVED AT ANY TIME DURING THE SURGICAL PROCEDURE. THE GROUNDING PAD WAS PROPERLY POSITIONED BY THE PATIENT'S THIGH. DURING THE SURGICAL PROCEDURE, A VIO300D ELECTROSURGICAL UNIT (ESU) WAS USED WITH A SWIFT COAG EFFECT MODE OF 4 AND 30W SETTING. THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS AND WAS IN STABLE CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI LOBECTOMY PROCEDURE, THE SURGICAL STAFF ALLEGEDLY NOTICED AN ELECTRIC CURRENT LEAK FROM THE RESIN PORTION OF THE PERMANENT CAUTERY SPATULA (PCS) INSTRUMENT . IT WAS ALSO REPORTED THAT THE PATIENT'S TISSUE AND THE AREA AROUND THE RESIN PORTION OF THE INSTRUMENT WERE BURNED. REPORTEDLY THERE WAS NO BLEEDING AROUND THE TISSUE AREA THAT WAS BURNED. THE SURGICAL STAFF REPORTEDLY REPLACED THE PCS INSTRUMENT WITH A BACKUP INSTRUMENT AND THE PLANNED PROCEDURE WAS COMPLETED WITH NO ADDITIONAL PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202908 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-06 M10110922 404

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other DA VINCI SI SURG SYS INST., ACCESSORIES, & ESU