BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 3171114 · Received June 14, 2013

    Report

    Report Number
    2955842-2013-02179
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 22, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. RECEIVED THE INSTRUMENT INVOLVED WITH THE COMPLAINT. ENGINEERING CONFIRMED THAT THE INSTRUMENT WAS STILL STUCK TO THE STERILE ADAPTER (PLASTIC INSERT) BUT THE INSTRUMENT WAS REMOVED IN-HOUSE USING EXCESSIVE FORCE. UPON REMOVING INSTRUMENT, THERE WAS A PIECE OF METAL FOUND ON THE MAGNET AT BACK END OF CHASSIS CAUSING RESISTANCE BETWEEN CHASSIS AND STERILE ADAPTER AFTER MAKING CONTACT. ADDITIONAL OBSERVATION NOT REPORTED BY THE CUSTOMER WERE 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. SCRATCHES WERE SHORT IN LENGTH AND WERE NOT AXIALLY ALIGNED WITH THE TUBE. SCRATCHES MEASURED APPROXIMATELY 0.1185 AND 0.2960. NO OTHER DAMAGE FOUND. - EVIDENCE NOT CONCLUSIVE, BUT MAIN TUBE DAMAGE MAY BE DUE TO MISHANDLING. THE INSTRUMENTS & ACCESSORIES 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 MDR REPORTABLE EVENT; HOWEVER, THE DEEP SCRATCHES FOUND ON THE MAIN TUBE 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 AFTER A DA VINCI SI SURGICAL PROCEDURE HAD COMPLETED, THE MEGA NEEDLE DRIVER INSTRUMENT WOULD NOT SLIDE/DISCONNECT FROM THE ARM-IT IS STILL STUCK TO PLASTIC INSERT. NO MISSING OR FALLEN PIECES WERE REPORTED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270307 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-08 M10121107 039

    Patients

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