BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 4003143 · Received August 12, 2014

    Report

    Report Number
    2955842-2014-04897
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 16, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE INSTRUMENT'S HOUSING WAS REMOVED TO FIND A ROLL CABLE BROKEN AT THE BACKEND. THE ROLL MOTION WAS NON INTUITIVE AS A RESULT. OTHER CABLES AT THE BACKEND WERE NOT DAMAGED. ADDITIONAL FINDINGS BY FAILURE ANALYSIS FOUND THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED. 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 MAIN TUBE SCRATCHES IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT FELT UNINTUITIVE AND UPON RE-INSPECTION ONE OF THE SMALL CABLES WAS FOUND TO BE DAMAGED. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. 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
    477888 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-11 M10140324 080

    Patients

    Seq Age Sex Outcome Treatment
    1