BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3935515 · Received July 15, 2014

    Report

    Report Number
    2955842-2014-04291
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 19, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND ONE GRIP CLOSE CABLE BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT DAMAGE. THE CABLE SEGMENT STUCK OUT AT THE INSTRUMENT'S WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE BROKEN CABLE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING, AN UNKNOWN ISSUE OCCURRED ON THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT. THE INSTRUMENT WAS NOT USED ON A PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT. NOTHING REPORTEDLY FELL INTO THE PATIENT. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. CONTACTED CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE UNKNOWN COMPLAINT DESCRIPTION. CUSTOMER INDICATED THAT THE WIRES WERE DISCONNECTED, POPPED OUT, MEANING FRAYED OR BROKEN. NOTHING FELL INTO THE PATIENT AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414280 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-03 M10131111 234

    Patients

    Seq Age Sex Outcome Treatment
    1