BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC GRASPER INSTRUMENT

    MDR report key: 3814028 · Received May 15, 2014

    Report

    Report Number
    2955842-2014-03020
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    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, FAILURE ANALYSIS INVESTIGATION OBSERVED THAT THE INSTRUMENT'S MAIN TUBE EXHIBITED SCRATCH MARKS/ABRASIONS. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .062 - .033 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. EVIDENCE NOT CONCLUSIVE, BUT DAMAGE MAY HAVE BEEN CAUSED BY MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S MAIN TUBE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RANDOM CHECK OF INSTRUMENTS, THE CUSTOMER NOTED THAT THE THORACIC GRASPER INSTRUMENT'S INSULATION WAS DAMAGED. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292375 THORACIC GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420343-01 S10130606 192

    Patients

    Seq Age Sex Outcome Treatment
    1