BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3063345 · Received April 17, 2013

    Report

    Report Number
    2955842-2013-01266
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 21, 2013
    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. ENGINEERING FOUND BOTH GRIP CABLES ON ONE SIDE OF THE DISTAL CLEVIS WERE DERAILED FROM THE DISTAL IDLER PULLEYS. THE GRIP OPEN CABLE WAS SEATED ON THE OUTERMOST PULLEY AND THE GRIP CLOSE CABLE WAS EXPOSED ON THE OUTSIDE OF THE PULLEY. THE YAW MOTION WAS NON-INTUITIVE AS A RESULT OF THE DERAILED CABLES. OTHER CABLES AT THE INSTRUMENT'S WRIST WERE NOT DAMAGED. ADDITIONAL OBSERVATION NOT INITIALLY REPORTED BY THE SITE WAS DEEP SCRATCHES ON THE MAIN TUBE. ENGINEERING EVALUATION ALSO FOUND THAT THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE 0.090 - 0.110 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THAT THE DAMAGE MAY BE DUE TO MISHANDLING. ELECTRICAL CONTINUITY TESTING WAS PERFORMED ON THE INSTRUMENT AND PASSED. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    DURING CENTRAL PROCESSING, THE USER FACILITY IDENTIFIED A DERAILED CABLE ON THE PROGRASP FORCEPS INSTRUMENT. IT WAS REPORTED THAT NOTHING FELL IN A PATIENT AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164390 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M12121101 201

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES