BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SHEARS INSTRUMENT

    MDR report key: 3150565 · Received June 6, 2013

    Report

    Report Number
    2955842-2013-02016
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 10, 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
    WA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE SCISSORS WERE DULL. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM FOR A LATEX CUT TEST AND THE SCISSORS DID NOT CUT CLEANLY THROUGH (B)(4) LATEX. THE BLADES WERE UNDAMAGED. THE BLADES EXHIBITED WEAR AT THE TIPS AFFECTING CUT PERFORMANCE. 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. 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 (B)(4) OF THE DISTAL END OF THE INSTRUMENT SHAFT. 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 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
    249937 MONOPOLAR CURVED SHEARS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10130307 437

    Patients

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