BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3975729 · Received August 4, 2014

    Report

    Report Number
    2955842-2014-04685
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 22, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND PASSED ENGAGEMENT AND RECOGNITION TESTING. A CAUTERY TEST WAS PERFORMED AND THE INSTRUMENT PASSED. THE INSTRUMENT WAS ABLE TO PASS ENERGY TESTING AS WELL AS ELECTRICAL CONTINUITY TESTING. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS AND ABRASIONS. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .143 - .088 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE MAIN TUBE FOUND DURING FAILURE ANALYSIS 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 HYSTERECTOMY SURGICAL PROCEDURE, THE CAUTERY FUNCTION WOULD NOT WORK ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT. THE CORD WAS DOUBLE CHECKED AND REPLACED WITHOUT ANY CHANGE IN FUNCTION. THE INSTRUMENT WAS THEN CHANGED AND THE CAUTERY WAS THEN FUNCTIONAL. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454408 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-14 N10140616 102

    Patients

    Seq Age Sex Outcome Treatment
    1