BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA GRASPER INSTRUMENT

    MDR report key: 3050891 · Received April 10, 2013

    Report

    Report Number
    2955842-2013-01182
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 12, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE LUER PLATE WAS DISLODGED FROM THE CHASSIS AND STUCK IN PAST THE CHASSIS BACKEND. ENGINEERING CONCLUDED THAT THE DAMAGE WAS MOST LIKELY DUE TO IMPROPER CLEANING. ENGINEERING ALSO FOUND VARIOUS SCRATCH MARKS ON THE DISTAL END OF THE MAIN TUBE SHOWING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE 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. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE DAMAGE TO THE INSTRUMENT'S MAIN TUBE, WHICH WAS FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REPROCESSING THE DA VINCI SI SURGICAL COBRA GRASPER INSTRUMENT PORT FELL IN WHILE BEING CLEANED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153905 COBRA GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420190-07 M10100616 038

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM, INSTRUMENTS AND ACCESSORIES