BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3980053 · Received August 5, 2014

    Report

    Report Number
    2955842-2014-04708
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 8, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER REPORTED COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. REMOTEFE DATA FOUND THAT THE INSTRUMENT WAS USED ON 6 OCCASIONS AND HAD 4 REMAINDER LIVES LEFT. ADDITIONAL OBSERVATIONS BY FAILURE ANALYSIS FOUND THE INSTRUMENT TUBE EXTENSION HAD PAD PRINTING REMOVED. THE TUBE EXTENSION HAD SEVERAL DEEP SCRATCH MARKS THAT HAD REMOVED THE PAD PRINTING. SCRATCH MARKS MEASURED APPROXIMATELY .199' X .062. FAILURE ANALYSIS CONCLUDED, PAD PRINTING REMOVED WAS DUE TO MISHANDLING/MISUSE. ADDITIONAL FINDINGS WERE THE INSTRUMENT'S DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED. THE SCRATCHES WERE .132- .219 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL 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 PAD PRINTING AND MAIN TUBE DAMAGES WERE TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BRAND NEW MONOPOLAR CURVED SCISSORS INSTRUMENT WAS PLUGGED INTO THE MACHINE AND IT ONLY REPORTED 8 LIVES WHEN IT SHOULD HAVE BEEN 10 LIVES. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457742 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M12130615 015

    Patients

    Seq Age Sex Outcome Treatment
    1