BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3821763 · Received May 20, 2014

    Report

    Report Number
    2955842-2014-03102
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND A BROKEN GRIP CABLE AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND WAS NOT DAMAGED. THE CABLE SEGMENT STUCK OUT AT THE INSTRUMENT'S WRIST. IN ADDITION, THE PITCH CABLE WAS FOUND TO BE FRAYED AT THE DISTAL IDLER. ADDITIONAL OBSERVATION NOT REPORTED WAS THERE WERE MECHANICAL INDENTATIONS AT THE INNER EDGE AND OUTER EDGE OF THE DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE PULLEY. NO OTHER DAMAGE WAS FOUND. FAILURE ANALYSIS CONCLUDED THAT THE INDENTATIONS WERE LIKELY DUE TO MISHANDLING. 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 REPORTABLE EVENT; HOWEVER, THE BROKEN AND FRAYED CABLES COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTIONS WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, A BROKEN WIRE WAS IDENTIFIED ON A MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT. ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT. NOTHING REPORTEDLY FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298303 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120131 659

    Patients

    Seq Age Sex Outcome Treatment
    1