BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER

    MDR report key: 2873238 · Received December 13, 2012

    Report

    Report Number
    2955842-2012-01306
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    August 28, 2012
    Report Date
    November 15, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED ONE GRIP CLOSE CABLE IS BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPINS FREELY AND WAS NOT DAMAGED. THE CABLE SEGMENT STICKS OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST ARE NOT DAMAGED. ADDITIONAL FINDINGS REVEALED A DERAILED GRIP CABLE. THE GRIP CABLE IS DERAILED AT THE DISTAL IDLER PULLEY. THE CABLE DERAILMENT IS LIKELY DUE TO THE CABLE LOSING CONTACT WITH PULLEY DURING WRIST ARTICULATION. THE FLEET ANGLE BETWEEN PROXIMAL AND DISTAL PULLEYS MAY CONTRIBUTE TO THE DERAILMENT. THE INSTRUMENT HAS 4 USES LEFT THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CUSTOMER NOTICED THAT THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT HAD A CABLE STICKING OUT OF THE JAW. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGA SUTURECUT NEEDLE DRIVER ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120410 650

    Patients

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