BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3081623 · Received April 29, 2013

    Report

    Report Number
    2955842-2013-01433
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 30, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION WAS UNABLE TO CONFIRM THE ALLEGED ISSUE THAT THE INSTRUMENT WAS NOT WORKING. THE INSTRUMENT WAS PLACED ON AN IS3000 SYSTEM AND DRIVEN. THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE INSTRUMENT'S GRIPS OPENED AND CLOSED PROPERLY. FUNCTIONAL PERFORMANCE TESTING OF THE INSTRUMENT DID NOT FIND ANY ISSUES. ENGINEERING EVALUATION FOUND VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL ON THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE. THE SCRATCHES WERE .080 - .100 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING EVALUATION CONCLUDED THAT THE MAIN TUBE DAMAGE WAS LIKELY CAUSED BY MISHANDLING/MISUSE. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI PANCREATECTOMY PROCEDURE, THE SURGICAL STAFF ALLEGED THAT PROGRASP FORCEPS INSTRUMENT BROKE AND WAS NOT WORKING. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184892 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10130201 939

    Patients

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