BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC GRASPER INSTRUMENT

    MDR report key: 3061953 · Received April 16, 2013

    Report

    Report Number
    2955842-2013-01260
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THAT THE BLACK TUBE INSULATION WAS DAMAGED AT THE DISTAL END. THE INSULATION WAS GOUGED ON ONE SIDE AND HAD VARIOUS SECTIONS LIFTED UP. A 0.025 X 0.025 PIECE WAS MISSING ROUGHLY 0.230 ABOVE THE INSTRUMENT'S SNAKE WRIST. THE SITE ALSO RETURNED A COUPLE 5MM CANNULAS EXHIBITING DAMAGE WHICH MAY HAVE CONTRIBUTED TO TUBE INSULATION DAMAGE (REFER TO MFR REPORT 'S 2955842-2013-01258 AND 2955842-2013-01259. NO OTHER DAMAGE WAS 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

    PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE USER FACILITY IDENTIFIED THE INSULATION FROM THE THORACIC GRASPER STRIPPED OFF AS A RESULT OF AN OUT OF ROUND CANNULA. THE REPORTER INDICATED NOTHING FELL IN A PATIENT. THE INSTRUMENT REPORTEDLY WAS NOT USED ON A PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163360 THORACIC GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420343-01 S10110629 893

    Patients

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