BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3981190 · Received August 5, 2014

    Report

    Report Number
    2955842-2014-04722
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 7, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND UPON VISUAL INSPECTION THE PITCH CABLE WAS LOOSE BUT UNDAMAGED AT THE DISTAL END. THE BLUE HOUSING WAS REMOVED AND THE PITCH CABLE WAS FOUND DERAILED FROM THE CLAMPING PULLEY. THE DERAILED CABLE CAUSED LOST TENSION AND CAN CAUSE IMPROPER MOTION OF THE INSTRUMENT. FAILURE ANALYSIS ALSO OBSERVED THAT THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .222 - .133 IN LENGTH AND 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 TUBE ABRASIONS WITH MATERIAL REMOVED, FOUND DURING FAILURE ANALYSIS EVALUATION 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 THE PK DISSECTING FORCEPS INSTRUMENT WAS NOT WORKING AS IT SHOULD, IT SOUNDED LIKE SOMETHING WAS LOOSE INSIDE DURING A DA VINCI SURGICAL PROCEDURE. NO FRAGMENTS FELL INTO THE 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
    458073 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 N10140306 014

    Patients

    Seq Age Sex Outcome Treatment
    1