BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 3130908 · Received May 24, 2013

    Report

    Report Number
    2955842-2013-01846
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 3, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE INSTRUMENT SHOWED A CHAR MARK ON THE YAW PULLEY IN BETWEEN THE CONDUCTOR WIRE AND DRIVE CABLE. ALSO, LIGHT CHARRING WAS FOUND ON THE INNER SURFACE OF ONE DISTAL CLEVIS EAR. ENGINEERING EVALUATION INDICATED THAT THE CHAR MARKS WERE EVIDENCE OF AN ARCING EVENT. ENGINEERING EVALUATION ALSO FOUND A DAMAGED CONDUCTOR WIRE. THE CONDUCTOR WIRE INSULATION HAD A SECTION MISSING ADJACENT TO THE CHAR MARK ON THE YAW PULLEY. BARE WIRE ON THE CONDUCTOR WIRE WAS OBSERVED TO BE EXPOSED. ELECTRICAL CONTINUITY TESTING OF THE INSTRUMENT PASSED. ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM A NURSING SUPERVISOR AT THE SITE. THE NURSING SUPERVISOR PROVIDED THE FOLLOWING INFORMATION: THE SURGICAL PROCEDURE WAS NOT RECORDED. THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS INSPECTED BEFORE THE SURGICAL PROCEDURE WAS PERFORMED AND NO ISSUES WERE OBSERVED. SHE ALSO INDICATED THAT THE INSTRUMENT WAS IN USE FOR ABOUT 10 MINUTES BEFORE THE ARCING EVENT WAS FIRST NOTICED. DUE TO THE ALLEGED ARCING ISSUE, THE SURGICAL STAFF REMOVED AND REPLACED THE PERMANENT CAUTERY SPATULA INSTRUMENT WITH ANOTHER SPATULA INSTRUMENT. AT THE TIME THE ARCING EVENT OCCURRED, A FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ALSO IN USE. THE NURSING SUPERVISOR DENIED THAT THERE WERE ANY INSTRUMENT COLLISIONS DURING THE SURGICAL PROCEDURE. SHE INDICATED THAT THE ELECTRIC ENERGY ARCED FROM THE PERMANENT CAUTERY SPATULA INSTRUMENT TO OTHER INSTRUMENTS. AT THE TIME THE ARCING EVENT OCCURRED, THE SITE WAS USING A VALLEY LAB ELECTROSURGICAL GENERATOR UNIT (ESU) WITH A SETTING OF 35 FOR CUTTING AND COAGULATION. THE NURSING SUPERVISOR INDICATED THAT THE GROUNDING PAD WASH POSITIONED CORRECTLY. SHE DENIED THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF ALLEGED THAT ARCING WAS OBSERVED WITH THE PERMANENT CAUTERY SPATULA INSTRUMENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231435 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-06 M10130307 347

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR DA VINCI SI SURG SYS INST., ACCESSORIES, & ESU