BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SHEARS INSTRUMENT

    MDR report key: 3150014 · Received June 6, 2013

    Report

    Report Number
    2955842-2013-02014
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 10, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS CHECKED FOR RECOGNITION ON AN IN-HOUSE SYSTEM AND THE INSTRUMENT WAS SUCCESSFULLY RECOGNIZED ON MULTIPLE ATTEMPTS. THE POGO PINS WERE NOT STUCK OR CONTAMINATED. ENGINEERING WAS UNABLE TO REPLICATE RECOGNITION ISSUE. THE INSTRUMENT WAS DRIVEN AND MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. ADDITIONAL OBSERVATION THAT WAS NOT REPORTED BY THE CUSTOMER WERE MICRO-CRACKS FOUND AT THE DISTAL END OF THE TUBE. THE MICRO-CRACKS RUN IN THE AXIAL DIRECTION AND MEASURES APPROXIMATELY 0.334. THESE TYPES OF MICRO-CRACKS WILL NOT LEAD TO MECHANICAL FAILURE OF THE INSTRUMENT, HOWEVER, THERE IS A POTENTIAL FOR INSULATION FAILURE AFTER REPROCESSING, RESULTING IN A PATHWAY FOR ELECTROSURGICAL ENERGY TO LEAK TO TISSUE AND POTENTIALLY CAUSE UNINTENDED INJURIES. THE LOCATION OF THESE IS CONFINED TO 2CM OF THE DISTAL END OF THE INSTRUMENT SHAFT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI PROCEDURE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS NOT RECOGNIZED BY THE SYSTEM. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250125 MONOPOLAR CURVED SHEARS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M11130208 147

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES