BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3232484 · Received July 18, 2013

    Report

    Report Number
    2955842-2013-02584
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 19, 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
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE TUBE EXTENSION WAS BROKEN AND MISSING A PIECE AT THE PROXIMAL CLEVIS INTERFACE. THE CLEVIS WAS NOT DISLODGED FROM THE TUBE EXTENSION. THE EVIDENCE WAS INCONCLUSIVE, BUT THE TUBE EXTENSION LIKELY BROKE DUE TO EXCESSIVE SIDE LOADING OR OTHER MISHANDLING. ENGINEERING ALSO FOUND A SMALL CRACK AND DEEP SCRATCHES ON THE MAIN TUBE. THE DISTAL END OF THE MAIN TUBE HAD MULTIPLE SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES VARIED IN LENGTH AND WERE NOT AXIALLY ALIGNED WITH THE TUBE. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS LIKELY DUE TO MISHANDLING. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. AN 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 0.1195. 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 2 CM OF THE DISTAL END OF THE INSTRUMENT SHAFT. NO EVIDENCE OF ARCING WAS FOUND. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - 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 OF A BROKEN TUBE EXTENSION 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 DURING A DA VINCI SI SURGICAL PROCEDURE A SLIT WAS OBSERVED UNDER THE TIP OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. 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
    333263 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10130315 296

    Patients

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