BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 3881303 · Received June 18, 2014

    Report

    Report Number
    2955842-2014-03725
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 21, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THAT THE PITCH UP CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. THE OTHER CABLES AT THE WRIST WERE UNDAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE DAMAGED CABLE, 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 THE MEGA NEEDLE DRIVER INSTRUMENT WAS NOTED TO BE BROKEN PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE. THE ISI REPRESENTATIVE CONTACTED THE SITE FOR MORE INFORMATION AND LEARNED LATER THAT THE CABLE WAS BROKEN ON THE INSTRUMENT. NO FRAGMENTS FELL INTO THE PATIENT, NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357007 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-10 M10140206 283

    Patients

    Seq Age Sex Outcome Treatment
    1