BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER

    MDR report key: 2832210 · Received November 14, 2012

    Report

    Report Number
    2955842-2012-00922
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT FRAYED CABLE SECTIONS WERE STICKING OUT AT THE DISTAL IDLER PULLEY. THE GRIP CABLE WAS ALSO OBSERVED TO BE DERAILED. THE GRIPS WERE ABLE TO OPEN AND CLOSE, BUT THEIR MOVEMENT AND FUNCTIONALITY COULD NOT BE PRECISE. EVIDENCE NOT CONCLUSIVE, BUT CABLE DERAILMENT WAS LIKELY DUE TO CABLE LOSING CONTACT WITH THE PULLEY DURING WRIST ARTICULATION. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DAVINCI SI SURGICAL PROCEDURE, FRAYED CABLES WERE IDENTIFIED DURING SET UP ON THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGASUTURECUT NEEDLE DRIVER ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120427 640

    Patients

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