BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORSINSTRUMENT

    MDR report key: 3870009 · Received June 12, 2014

    Report

    Report Number
    2955842-2014-03593
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 15, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM FOR LATEX CUT TEST. THE SCISSORS DID NOT CUT CLEANLY THROUGH .006 OF LATEX. THE LATEX SNAGGED AT THE SCISSOR TIPS. THE BLADE EDGES WERE NOT DAMAGED BUT THE EDGES EXHIBITED WEAR AT THE TIPS, NEGATIVELY AFFECTING CUT PERFORMANCE. AN ADDITIONAL OBSERVATION NOT REPORTED WAS TUBE EXTENSION HAD PAD PRINTING REMOVED. THE TUBE EXTENSION EXHIBITED PAD PRINTING REMOVED MEASURING .042 LOCATED AT THE TUBE EXTENSION AND MAIN TUBE INTERFACE. FAILURE ANALYSIS CONCLUDED THE DAMAGE WAS LIKELY DUE TO MISHANDLING / MISUSE. AN ADDITIONAL OBSERVATION NOT REPORTED WAS THE BANANA PLUG WAS BENT TO THE SIDE. THERE WAS NO DAMAGE TO THE BACK END. FAILURE ANALYSIS CONCLUDED THE DAMAGE WAS LIKELY DUE TO MISHANDLING / MISUSE. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS DULL. NOTHING REPORTEDLY FELL INTO A 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
    347731 MONOPOLAR CURVED SCISSORSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M10140123 218

    Patients

    Seq Age Sex Outcome Treatment
    1