BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3112800 · Received May 14, 2013

    Report

    Report Number
    2955842-2013-01665
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 18, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Removal / Correction Number
    2955842-051613-005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT OF THE INSTRUMENT DULL SCISSORS. ENGINEERING PLACED THE INSTRUMENT ON AN IN-HOUSE SYSTEM FOR A LATEX CUT TEST AND THE SCISSORS CUT CLEANLY THROUGH (B)(4) LATEX. THE BLADES WERE UNDAMAGED. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. ENGINEERING FOUND A HAIRLINE CRACK AT THE DISTAL END OF THE MAIN TUBE. 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.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED FOR RETROSPECTIVE ACTIVITY PERFORMED RELATING TO FIELD ACTION NUMBER (B)(4) TO INVESTIGATE MICRO-CRACKS ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT. 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 THESES MICRO-CRACKS IS CONFINED TO (B)(4) OF THE DISTAL END OF THE INSTRUMENT SHAFT. THIS INSTRUMENT WAS INSPECTED AS PART OF THIS RETROSPECTIVE ACTIVITY AND FOUND TO CONTAIN CRACKS ON THE INSTRUMENT MAIN TUBE. THESE CRACKS WERE REPORTED ON THE INITIAL MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS NOTED TO BE DULL. 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
    213232 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M11130201 311

    Patients

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