BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3093972 · Received May 6, 2013

    Report

    Report Number
    2955842-2013-01553
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 1, 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 RECEIVED AND EVALUATED. ENGINEERING FOUND A DERAILED GRIP CABLE AT THE DISTAL IDLER PULLEY. THE GRIPS COULD STILL BE OPENED AND CLOSED, BUT MOVEMENT MAY NOT BE PRECISE. ADDITIONAL DAMAGE FOUND WAS DEEP SCRATCHES ON THE MAIN TUBE. THE DISTAL END OF THE MAIN TUBE HAD SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. ENGINEERING CONCLUDED THE DAMAGE WAS LIKELY DUE TO MISHANDLING. 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

    AFTER THE DA VINCI SI PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF FOUND A WIRE THAT CAME OFF FROM THE PULLEY OF THE PROGRASP FORCEPS INSTRUMENT WHEN THE STAFF IRRIGATED IT. DURING THE PROCEDURE, THE MOVEMENT OF THE INSTRUMENT WAS NORMAL. THERE WAS NO ALLEGATION OF PATIENT HARM OR FRAGMENTS FALLING INTO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197066 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10120725 987

    Patients

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