BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3388584 · Received October 4, 2013

    Report

    Report Number
    2955842-2013-03994
    Event Type
    Malfunction
    Date Received
    October 4, 2013
    Date of Event
    August 15, 2013
    Report Date
    September 9, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THAT THE TUBE EXTENSION WAS BROKEN AND MISSING A .188 X .150 PIECE AT THE PROXIMAL CLEVIS INTERFACE. THE CLEVIS WAS DISLODGED FROM TUBE EXTENSION. THE TUBE EXTENSION FRACTURED NEXT TO ONE OF THE KEYS THAT MATES WITH THE PROXIMAL CLEVIS. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. FAILURE ANALYSIS REMOVED THE HOUSING AND OBSERVED THAT THE FLUSH TUBE EXHIBITED A COUPLE OF KINKS IN THE BACKEND. THE KINKS OCCURRED PRIOR TO THE FLUSH TUBE ENTERING THE IDLER BLOCK. THE KINKS CAN RESTRICT FLUID FLOW, PREVENTING PROPER FLUSHING OF THE INSTRUMENT. FAILURE ANALYSIS ALSO OBSERVED THAT THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .090 - .460 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS O 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, IN A FRAGMENT-CAUSING FAILURE (SUCH AS A CABLE FAILURE, A CRIMP SEPARATING FROM A CABLE ETC.) FOR THE MCS INSTRUMENT THE TIP COVER ACCESSORY WILL HOLD SUCH FRAGMENTS INSIDE THE TIP COVER, PREVENTING LOSS INTO THE PATIENT DURING THE REMOVAL OF THE INSTRUMENT. BECAUSE THE TIP COVER ACTS AS A BARRIER, THESE FAILURES, WHICH MIGHT BE REPORTABLE IN OTHER INSTRUMENTS, ARE NOT REPORTABLE EVENTS FOR THE MCS INSTRUMENT; HOWEVER, THE MAIN TUBE WAS DAMAGED, 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 PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS NOTED TO BE CRACKED ON THE PART WHERE THE TIP COVER GOES IN. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504454 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M10130614 783

    Patients

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