BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE FENESTRATED GRASPER INSTRUMENT

    MDR report key: 3033959 · Received April 3, 2013

    Report

    Report Number
    2955842-2013-01103
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE INSTRUMENT WAS CHECKED FOR RECOGNITION ON AN IN-HOUSE SYSTEM SYSTEM, WHICH SUCCESSFULLY RECOGNIZED THE INSTRUMENT. THE INSTRUMENT'S POGO PINS DID NOT STICK OUT AND WERE NOT CONTAMINATED. THE DALLAS CHIP PROGRAMMER VERIFICATION OF THE INSTRUMENT PASSED. ENGINEERING EVALUATION ALSO FOUND CABLE AND MAIN TUBE ISSUES THAT WERE NOT REPORTED BY THE SITE. ONE GRIP CLOSE CABLE WAS LOOSE AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND WAS NOT DAMAGED. THE WIRE WAS ALSO LOOSE INSIDE THE HOUSING BY THE CLAMPING THE PULLEY BUT THE SCREWS WERE FOUND TO BE SECURED. THE IDLER BLOCK SHOWED NO SIGN OF DAMAGE. THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL AND HAD A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND WERE NOT AXIALLY ALIGNED WITH THE TUBE. ENGINEERING CONCLUDED THAT THE MAIN TUBE DAMAGE MAY DUE TO MISHANDLING. 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. INTUITIVE SURGICAL CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. 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

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE DOUBLE FENESTRATED GRASPER INSTRUMENT WAS NOT RECOGNIZED BY THE DA VINCI SI SYSTEM. REPORTEDLY THE INSTRUMENT WAS NOT USED ON 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
    137210 DOUBLE FENESTRATED GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420189-06 M10090505 438

    Patients

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