BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3895123 · Received June 25, 2014

    Report

    Report Number
    2955842-2014-03906
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 11, 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. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT'S GRIP CABLE WAS DERAILED. ONE GRIP CABLE WAS DERAILED AT THE DISTAL CLEVIS HUB. THE YAW MOTION WAS NON-INTUITIVE AS A RESULT. THE DISTAL CLEVIS HUB DID NOT EXHIBIT ANY WEAR. THE OTHER CABLES AT WRIST WERE NOT DAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS AND ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING, IT WAS NOTED THAT THE PROGRASP FORCEPS INSTRUMENT WOULD NOT ARTICULATE. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371286 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10130521 921

    Patients

    Seq Age Sex Outcome Treatment
    1