BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC GRASPER INSTRUMENT

    MDR report key: 3160747 · Received June 10, 2013

    Report

    Report Number
    2955842-2013-02102
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE BLACK TUBE INSULATION WAS DAMAGED AT THE DISTAL END. THE INSULATION WAS GOUGED ON ONE SIDE AND HAD A .100 X .080 PIECE MISSING ROUGHLY 4 ABOVE THE SNAKE WRIST. NO OTHER DAMAGE WAS FOUND. 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 REPROCESSING THE DA VINCI SI SURGICAL THORACIC GRASPER INSTRUMENT WAS NOTED TO HAVE A CUT IN THE INSULATION ON THE SHAFT OF THE INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260776 THORACIC GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420343-01 S10130214 108

    Patients

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