BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3211868 · Received July 8, 2013

    Report

    Report Number
    2955842-2013-02463
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 30, 2013
    Report Date
    June 12, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE INSTRUMENT GRIP CABLE WAS BROKEN AT THE DISTAL END. THE BROKEN CABLE SEGMENT STUCK OUT AT THE WRIST AT APPROXIMATELY .2715 IN LENGTH. THE IDLER PULLEY SPUN FREELY AND WAS UNDAMAGED. THE OTHER CABLES AT THE WRIST WERE UNDAMAGED. ENGINEERING ALSO FOUND PAD PRINTING REMOVAL AND CRACKS ON THE INSTRUMENT'S MAIN TUBE. THE TUBE EXTENSION EXHIBITED A SECTION WITH PAD PRINTING REMOVAL NEAR THE PROXIMAL CLEVIS INTERFACE. THE TUBE EXTENSION WAS NOT BROKEN. FAILURE ANALYSIS WAS PERFORMED ON THIS INSTRUMENT IN RELATION TO FIELD ACTION (B)(4) TO INVESTIGATE MICRO CRACKS ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT. AS THE LOCATION OF THESES MICRO-CRACKS IS CONFINED TO 2CM OF THE INSTRUMENT SHAFT, THE FAILURE ANALYSIS WAS LIMITED TO ONLY THIS AREA OF THE INSTRUMENT. THE DISTAL END OF THE MAIN TUBE EXHIBITED A COUPLE OF HAIRLINE CRACKS IN THE AXIAL DIRECTION. THE CRACKS WERE ROUGHLY .4380, .3365, .4735, AND .4010 IN LENGTH. NO OTHER DAMAGE WAS FOUND. THERE WAS NO EVIDENCE OF ARCING. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE PAD PRINTING REMOVED, 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 NEPHRECTOMY PROCEDURE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT STOPPED PERFORMING WELL AND WASN NOT MOVING IN A NORMAL FASHION. BROKEN FIBERS WERE OBSERVED AT THE TIP OF THE SCISSORS. 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
    309509 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10121012 244

    Patients

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