BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3212031 · Received July 8, 2013

    Report

    Report Number
    2955842-2013-02466
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 6, 2013
    Report Date
    June 12, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    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 A BROKEN GRIP AT THE DISTAL END. THE BROKEN CABLE SEGMENT STUCK OUT AT THE WRIST AT APPROXIMATELY .4285 IN LENGTH. THE IDLER PULLEY SPUN FREELY BUT WAS DAMAGED. THE PULLEY EXHIBITED SMALL MECHANICAL INDENTATION AT THE EDGE. THE OTHER CABLES AT THE WRIST WERE UNDAMAGED. ADDITIONAL DAMAGES FOUND WERE PAD PRINTING REMOVAL AND BENT BANANA PLUG. THE TUBE EXTENSION EXHIBITED A SECTION WITH PAD PRINTING REMOVAL NEAR THE PROXIMAL CLEVIS INTERFACE. THE TUBE EXTENSION WAS UNBROKEN. THE BANANA PLUG WAS BENT AT THE BACK OF THE HOUSING. THE EVIDENCE WAS INCONCLUSIVE BUT THE DAMAGE WAS LIKELY DUE TO MISHANDLING. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. 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 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 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 S SURGICAL PROCEDURE THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS ALLEGEDLY NOT RESPONDING APPROPRIATELY TO THE SURGEON'S HAND MOVEMENT. UPON REMOVAL OF THE INSTRUMENT, IT WAS OBSERVED ONE OF THE INSTRUMENT WIRES WAS BROKEN. 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
    308845 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M12130211 596

    Patients

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