BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3738409 · Received April 10, 2014

    Report

    Report Number
    2955842-2014-02127
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 17, 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. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED COMPLAINT. NO TROUBLE WAS FOUND. THE GRIP CABLES AT THE END OF THE INSTRUMENT WERE ON THE PULLEYS. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENT'S GRIP CABLE WAS DERAILED. THE GRIP CABLE WAS DERAILED ON THE PROXIMAL END AT THE HOUSING. THE GRIPS WERE DIFFICULT TO MOVE BECAUSE OF THE DERAILMENT. 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 .162 - .303 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY SURGICAL PROCEDURE, IT WAS NOTED THAT THE MOTION OF THE PROGRASP FORCEPS INSTRUMENT WAS BAD. UPON INSPECTION OF THE TIP OF THE INSTRUMENT, IT WAS NOTED THE WIRE HAD DERAILED FROM THE PULLEY. THE WIRE WAS RETURNED TO ITS ORIGINAL POSITION USING TWEEZERS, BUT WAS UNSTABLE. THE SURGICAL PROCEDURE WAS COMPLETED USING A BACK UP INSTRUMENT. 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
    217957 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10130501 325

    Patients

    Seq Age Sex Outcome Treatment
    1