BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3920375 · Received July 8, 2014

    Report

    Report Number
    2955842-2014-04168
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE GRIP CABLE WAS BROKEN AT THE DISTAL IDLERS. THE CABLE SEGMENT STUCK OUT AT THE INSTRUMENT'S WRIST. THE IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT ANY DAMAGE. THE OTHER CABLES AT THE INSTRUMENT'S WRIST WERE INTACT AND UNDAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND INDENTATIONS AT THE EDGE OF THE INSTRUMENT'S DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE PULLEY. IT WAS CONCLUDED THAT THE INDENTATION DAMAGE FOUND TO THE DISTAL PULLEY WAS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. 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. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE BROKEN CABLE, IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REPROCESSING OF A DA VINCI MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT, A CABLE WAS IDENTIFIED AS STICKING OUT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT, AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397559 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-03 M10140306 643

    Patients

    Seq Age Sex Outcome Treatment
    1