BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM MONOPOLAR CAUTERY INSTRUMENT

    MDR report key: 2960685 · Received January 25, 2013

    Report

    Report Number
    2955842-2013-00305
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 28, 2012
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE ALLEGED COMPLAINT OF INSTRUMENT'S CASING BEING TORN WAS CONFIRMED. THE INSTRUMENT'S MAIN TUBE INSULATION APPEARED TO HAVE SCRATCHES AND GOUGE MARKS WITH MATERIAL REMOVED AT THE DISTAL END. EVIDENCE IS NOT CONCLUSIVE, BUT THE DAMAGE WAS LIKELY CAUSED BY EXCESS FORCE CONTACT ON THE MAIN TUBE SURFACE. THE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. PER THE CUSTOMER, AT THE TIME OF THE REPORTED EVENT, NOTHING FELL INTO A PT DURING A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, THE SURGICAL STAFF ALLEGED THAT THE "CASING" OF A MONOPOLAR CAUTERY INSTRUMENT WAS TORN. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35463 5MM MONOPOLAR CAUTERY INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT, NAY NAY INTUITIVE SURGICAL, INC. 420142-04 S10120525 613

    Patients

    Seq Age Sex Outcome Treatment
    1 ESU| DA VINCI SI SURGICAL SYSTEM| ACCESSORIES