BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 3822087 · Received May 20, 2014

    Report

    Report Number
    2955842-2014-03113
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS 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 MDR REPORTABLE EVENT; HOWEVER; THE BROKEN CABLE 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 PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, A BROKEN CABLE AT THE WRIST OF THE LARGE SUTURECUT NEEDLE DRIVER WAS IDENTIFIED. NOTHING REPORTEDLY FELL INTO A 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
    299796 LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420296-04 M10140324 227

    Patients

    Seq Age Sex Outcome Treatment
    1