BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3944814 · Received July 18, 2014

    Report

    Report Number
    2955842-2014-04397
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT ONE GRIP CLOSE CABLE WAS BROKEN AT THE DISTAL IDLERS. THE CABLE SEGMENT STUCK OUT AT THE INSTRUMENT'S WRIST APPROXIMATELY .449. THE IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT ANY DAMAGE. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE BROKEN CABLE, IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, A BROKEN CABLE WAS OBSERVED ON THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT. THE INSTRUMENT WAS NOT USED IN THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT, AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422579 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-03 M10140122 295

    Patients

    Seq Age Sex Outcome Treatment
    1