BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 2944620 · Received February 5, 2013

    Report

    Report Number
    2955842-2013-00381
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE BLADE ON THE INSTRUMENT HAS A CHIP. ENGINEERING CONCLUDED THAT THE DAMAGE IS 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 REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF A DA VINCI SI SURGICAL PROCEDURE, IT WAS NOTED THAT THE BLADE ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT HAD A CHIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48936 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M11120409 462

    Patients

    Seq Age Sex Outcome Treatment
    1 DAV SI SURG SYSTEM, MCS TIP COVER ACCESSORY & ESU