BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3873105 · Received June 13, 2014

    Report

    Report Number
    2955842-2014-03649
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 15, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THAT THE INSTRUMENT PASSED A CUT TEST ON AN IN-HOUSE IS3000 SYSTEM. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING ADDITIONAL DAMAGES TO THE INSTRUMENT: THE INSTRUMENT MAIN TUBE WAS CRACKED. THE TUBE HAD A SMALL FISSURE IN THE AXIAL DIRECTION, LOCATED DIRECTLY BELOW THE TUBE REINFORCEMENT RING. THE LOCATION OF THE FISSURE WAS IN AN AREA THAT IS NOT PROTECTED BY TIP COVER. THE LOCATION AND TYPE OF MAIN TUBE CRACKING IDENTIFIED IN THIS REPORT DIFFERS FROM MAIN TUBE CRACKS CAPABLE OF LEAKING ELECTROSURGICAL ENERGY. THE LOCATION OF THESE CRACKS ON THE INSTRUMENT MAIN TUBE IN THIS REPORT IS LIMITED TO AN AREA WHERE THE MAIN TUBE OF THE INSTRUMENT COVERS THE EXTENSION INSERT, ESSENTIALLY PROVIDING DOUBLE INSULATION OF THE TUBE, WITH ADDITIONAL SILICONE SEAL ADHESIVE BONDING. THERE IS NO PARTING OF MATERIAL IN THESE CASES AND THERE IS NO PROPAGATION OR GROWTH OF THE CRACKS. THE CRACKS APPEAR TO BE A RESULT OF LEVERAGE FORCE CAUSED BY EXPOSING THE INSTRUMENT TIP TO EXCESSIVE SIDE LOAD FORCE OR MISHANDLING (FOR EXAMPLE INSTRUMENT DROPS). THERE ARE NO REPORTED CASES OF ENERGY LEAKAGE FROM CRACKS IN THIS AREA. PAD PRINTING WAS REMOVED FROM THE DISTAL END OF THE TUBE EXTENSION. THE REMOVED AREA MEASURED APPROXIMATELY .396 X .237. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST® INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE PAD PRINTING REMOVED, 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 THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS DULL DURING A DA VINCI PROSTATECTOMY PROCEDURE. NO FRAGMENTS FELL INTO THE PATIENT. 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
    349480 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M10140123 214

    Patients

    Seq Age Sex Outcome Treatment
    1