BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 3822085 · Received May 20, 2014

    Report

    Report Number
    2955842-2014-03110
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 22, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED ON AN IS3000 SYSTEM AND DRIVEN. RECOGNITION AND ENGAGEMENT PASSED. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTIONS IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. NO TROUBLE WAS FOUND AND THE ISSUE COULD NOT BE REPRODUCED. AN ADDITIONAL FINDING WAS VARIOUS SCRATCHES ON THE DISTAL END OF THE MAIN TUBE EXHIBITING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT AXIALLY ALIGNED WITH THE TUBE. ADDITIONALLY, THE TIPS OF THE INSTRUMENT'S GRIPS WERE CONTAMINATED. ONE GRIP HAD A BROWN COLORED RESIDUE VISIBLE. NO OTHER DAMAGE WAS FOUND. FAILURE ANALYSIS CONCLUDED THE DAMAGE WAS LIKELY DUE TO IMPROPER CLEANING. THE REPROCESSING INSTRUCTIONS UNDER CLEANING, DISINFECTION, AND STERILIZATION GENERAL INFORMATION SECTION SPECIFICALLY STATES: WARNING: READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW INSTRUCTIONS MAY CAUSE IMPROPER FUNCTIONING OF THE DEVICE. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE TUBE ABRASIONS WITH MATERIAL REMOVED, FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY 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 SACROCOLPOPEXY PROCEDURE, THE LARGE NEEDLE DRIVER INSTRUMENT WAS NOT ROTATING CORRECTLY. 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
    300480 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-06 M10130805 293

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR