BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC GRASPER

    MDR report key: 2964806 · Received February 15, 2013

    Report

    Report Number
    2955842-2013-00523
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 16, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED THAT DRIVE CABLES ARE BROKEN AT THE SNAKE WRIST. THE BROKEN SEGMENTS STICK OUT AT THE WRIST. WRIST WILL NOT STRAIGHTEN PROPERLY AND MOTION IS NON-INTUITIVE DUE TO CABLE BREAKAGE. OTHER CABLES AT WRIST ARE NOT DAMAGED. 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 A DA VINCI SI PULMONARY LOBECTOMY PROCEDURE, BROKEN WIRES WERE NOTICED ON THE THORACIC GRASPER INSTRUMENT. AS A RESULT, THERE WAS LIMITED MOVEMENT AND ARTICULATION POSSIBLE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69060 THORACIC GRASPER ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420343-01 S10120320 620

    Patients

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