BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM MARYLAND DISSECTOR INSTRUMENT

    MDR report key: 2991910 · Received March 6, 2013

    Report

    Report Number
    2955842-2013-00759
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    November 2, 2012
    Report Date
    February 5, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE OF A BROKEN CABLE; HOWEVER, EVALUATION FOUND THAT THE MAIN TUBE INSULATION HAD SCRATCHES AND GOUGE MARKS, WITH MATERIALS REMOVED AT THE DISTAL END. ENGINEERING CONCLUDED THAT DAMAGE TO THE MAIN TUBE WAS LIKELY CAUSED BY EXCESS FORCE CONTACT ON SURFACE OF THE MAIN TUBE. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS O HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. O 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. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI TONGUE BASE RESECTION PROCEDURE, THE CABLE ON THE MARYLAND DISSECTOR INSTRUMENT BROKE. NO MISSING OR FALLEN PIECES WERE REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95319 5MM MARYLAND DISSECTOR INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420143-04 S10100618 226

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURG SYSTEM, ACCESSORIES AND ESU.