BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3945763 · Received July 21, 2014

    Report

    Report Number
    2955842-2014-04421
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 27, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION WAS NOT ABLE TO VERIFY THE REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND DRIVEN. THE RECOGNITION AND ENGAGEMENT PASSED. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE BLADES OPENED AND CLOSED PROPERLY. FAILURE ANALYSIS ALSO OBSERVED THE FOLLOWING UNREPORTED DAMAGES: THE INSTRUMENT FAILED THE FUNCTIONAL TEST. THE SCISSORS DID NOT CUT CLEANLY THROUGH .006 LATEX. THE LATEX GETS SNAGGED AT THE SCISSORS TIPS. THE BLADE EDGES ARE NOT DAMAGED, BUT THE EDGES EXHIBITED WEAR AT THE TIPS, NEGATIVELY AFFECTING CUT PERFORMANCE. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE AFFECTED AREAS MEASURED APPROXIMATELY 2.45 IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE MAIN TUBE MATERIAL REMOVAL FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI RETROPERITONEAL MASS RESECTION, LEFT PROCEDURE, THE ROBOTIC MONOPOLAR CURVED SCISSORS INSTRUMENT WAS NOT RECOGNIZED BY THE ROBOTIC SYSTEM. NOTHING FELL INTO THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426638 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 N10140506 542

    Patients

    Seq Age Sex Outcome Treatment
    1