BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3940983 · Received July 17, 2014

    Report

    Report Number
    2955842-2014-04344
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 23, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION OBSERVED THAT THE INSTRUMENT'S PITCH CABLE WAS FOUND TO BE FRAYED. THE CONDUCTOR WIRES WERE INTACT AND UNDAMAGED, BUT DRIVE CABLE WAS FRAYED. THE PITCH DOWN CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. THE FRAYED STRANDS STUCK OUT AT THE WRIST. OTHER CABLES AT WRIST WERE NOT DAMAGED. THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE OF INSTRUMENT DID NOT OPEN/CLOSE. THE INSTRUMENT PASSED A FRICTION TEST ON AN INSTRUMENT PERFORMANCE TESTER (IPT). NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S PITCH CABLE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI CHOLECYSTECTOMY PROCEDURE, THE CUSTOMER NOTED THAT THE PROGRASP FORCEPS INSTRUMENT CABLE WAS BROKEN AND THEREAFTER THE INSTRUMENT WOULD NOT OPEN OR CLOSE. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. 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
    419769 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-11 M10140318 376

    Patients

    Seq Age Sex Outcome Treatment
    1