BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 3892546 · Received June 24, 2014

    Report

    Report Number
    2955842-2014-03865
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 11, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE INITIAL REPORTER'S COMPLAINT. THE INSTRUMENT GRIP CABLE WAS FRAYED AT THE DISTAL IDLER PULLEY. THE FRAYED STRANDS STUCK OUT AT THE WRIST. THE OTHER CABLES WERE NOT DAMAGED. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS THAT THE INSTRUMENT DISTAL PULLEYS HAD SCRATCH MARKS/ABRASIONS. THERE ARE SCRATCHES ON THE SURFACE OF THE DISTAL PULLEY. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS THAT THE INSTRUMENT GRIP TIPS HAD MECHANICAL INDENTATIONS/BURRS. THERE WAS AN INDENTATION AT THE SIDE OF THE GRIP WITH A VISIBLE SCRATCH ON THE SURFACE. EVIDENCE NOT CONCLUSIVE, BUT MECHANICAL INDENTATIONS/BURRS DAMAGE MAY BE DUE TO LIKELY MISHANDLING/MISUSE. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS O 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 REPORTED MALFUNCTION OF A BROKEN GRIP CABLE TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER A DA VINCI SURGICAL PROCEDURE, THE CABLE BROKE FROM THE MEGA NEEDLE DRIVER INSTRUMENT. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368373 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-10 M10131123

    Patients

    Seq Age Sex Outcome Treatment
    1