BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3930986 · Received July 13, 2014

    Report

    Report Number
    2955842-2014-04236
    Event Type
    Malfunction
    Date Received
    July 13, 2014
    Date of Event
    May 28, 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
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION OBSERVED THAT THE GRIP CABLE WAS DERAILED. THE INSTRUMENT HOUSING WAS REMOVED TO FIND THAT THE FRIP CABLE WAS DERAILED AT THE CLAMPING PULLEY. OTHER BACKEND CABLES WERE NOT DAMAGED. AN ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THAT THE INSTRUMENT'S MAIN TUBE EXHIBITED SCRATCH MARKS/ABRASIONS. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S MAIN TUBE FOUND DURING FAILURE ANALYSIS INVESTIGATION COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SACROCOLPOPEXY PROCEDURE, THE CUSTOMER NOTED THAT THE PROGRASP FORCEPS INSTRUMENT WOULD NOT SMOOTHLY OPEN AND CLOSE. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409043 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-11 M10140220 920

    Patients

    Seq Age Sex Outcome Treatment
    1