BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORSINSTRUMENT

    MDR report key: 3882267 · Received June 18, 2014

    Report

    Report Number
    2955842-2014-03757
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 21, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND ONE BLADE EDGE HAD AN INDENTATION BETWEEN THE MIDPOINT AND THE TIP WHICH ACTED AS A MECHANICAL STOP FOR THE OTHER BLADE WHEN CLOSING. AS A RESULT, THE BLADES DID NOT CUT THROUGH THE ENTIRE LENGTH AND WAS UNABLE TO PERFORM A CUT TEST. THE INSTRUMENT WAS EXPIRED. FAILURE ANALYSIS CONCLUDED THE INDENTATIONS WERE LIKELY DUE TO MISHANDLING / MISUSE. 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. AN ADDITIONAL FINDING WAS VARIOUS SCRATCHES ON THE DISTAL END OF THE MAIN TUBE SHOWING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .233 - .186 IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. NO OTHER DAMAGE WAS FOUND. THE RETURNED INSTRUMENT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE TUBE ABRASIONS WITH MATERIAL 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

    NO COMPLAINT WAS COMMUNICATED TO INTUITIVE SURGICAL REGARDING PERFORMANCE OF THE DA VINCI SURGICAL SYSTEM. NO MALFUNCTION OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS ALLEGED AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358697 MONOPOLAR CURVED SCISSORSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M13120814 193

    Patients

    Seq Age Sex Outcome Treatment
    1