BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3180834 · Received June 20, 2013

    Report

    Report Number
    2955842-2013-02248
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 23, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. THE INSTRUMENT WAS BROKEN AT THE PROXIMAL CLEVIS TO THE MAIN TUBE INTERFACE. THE CLEVIS WAS DISLODGED FROM THE MAIN TUBE AS A RESULT. THE DAMAGE WAS SO SEVERE THAT INSTRUMENT COULD NOT BE INSTALLED THRU THE DISTAL END OF A CANNULA IN IT'S CONDITION. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS A CRACKED TUBE. ONE SECTION OF THE MAIN TUBE INTERFACE WALL HAD COLLAPSED AND THE DISTAL END OF TUBE WAS CRACKED IN THE AXIAL DIRECTION. ENGINEERING CONCLUDED THE BREAKAGE WAS LIKELY DUE TO OVERLOADING AT THE INSTRUMENT'S TIP. 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. 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 PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE THE TIP OF A PROGRASP FORCEPS INSTRUMENT WAS BENT AND NOT USABLE. NOTHING REPORTEDLY FELL INTO A 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
    280338 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M11130214 683

    Patients

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