BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE SUTURE CUT NEEDLEDRIVERINSTRUMENT

    MDR report key: 3030769 · Received April 2, 2013

    Report

    Report Number
    2955842-2013-01074
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 5, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THAT THE GRIP CABLE WAS BROKEN AT THE DISTAL IDLERS AND WAS STICKING OUT AT THE INSTRUMENT'S WRIST. THE IDLER PULLEY SPUN FREELY AND WAS NOT DAMAGED. NO OTHER CABLES AT THE INSTRUMENT'S WRIST WERE DAMAGED. AN ADDITIONAL OBSERVATION NOTED BY ENGINEERING THAT WAS NOT REPORTED BY THE SITE WAS INDENTATION ON THE PULLEY. THERE WAS AN INDENTATION ON THE INNER CORE OF THE PULLEY AS WELL AS SCRATCHES ON THE SURFACE OF THE DISTAL PULLEY. 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 A DA VINCI S PROCEDURE AND DURING PROCESSING, THE USER FACILITY IDENTIFIED A BROKEN CABLE FROM THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT. REPORTEDLY THE INSTRUMENT WAS NOT USED ON A PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED. THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134350 LARGE SUTURE CUT NEEDLEDRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420296-02 M10121107 936

    Patients

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