BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND DISSECTOR INSTRUMENT

    MDR report key: 3685889 · Received March 18, 2014

    Report

    Report Number
    2955842-2014-01571
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 19, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MARYLAND DISSECTOR INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND NO TROUBLE. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND IT PASSED THE ENGAGEMENT AND THE RECOGNITION TEST. THE INSTRUMENT MOVED WITH FULL RANGE OF MOTION AND THE GRIPS OPENED AND CLOSED PROPERLY. THE CABLES WERE NOT DAMAGED AT THE DISTAL END NOR THE AT THE BACKEND OF THE INSTRUMENT, INSIDE THE HOUSING. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED EXPOSING THE MAIN TUBE. THE AREA WITH MISSING MATERIAL MEASURED ROUGHLY ABOUT .192 - .200 IN LENGTH AND WAS NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE JAWS CANNOT BE OPENED WELL ON THE MARYLAND DISSECTOR INSTRUMENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. NOTHING REPORTEDLY FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161705 MARYLAND DISSECTOR INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420143-04 S10130206 871

    Patients

    Seq Age Sex Outcome Treatment
    1