BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3832737 · Received May 27, 2014

    Report

    Report Number
    2955842-2014-03224
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    July 5, 2013
    Report Date
    May 7, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT'S TUBE EXTENSION WAS BROKEN AND MISSING A .152 X .263 PIECE AT THE PROX CLEVIS INTERFACE. THE BROKEN PIECE WAS NOT RETURNED, BUT IT WOULD BE CONTAINED IN THE TIP COVER. THE CLEVIS WAS DISLODGED FROM TUBE EXTENSION. FAILURE ANALYSIS CONCLUDED THE TUBE EXTENSION LIKELY BROKE DUE TO EXCESSIVE SIDE LOADING OR OTHER MISHANDLING/MISUSE. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENT'S MAIN TUBE HAD DEEP SCRATCH MARKS AND ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .018 - .175 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. FAILURE ANALYSIS CONCLUDED THAT THE SCRATCH DAMAGE MAY HAVE BEEN CAUSED BY MISHANDLING/MISUSE. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. THE FLUSH TUBE WAS NOT KINKED. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DA VINCI BENIGN HYSTERECTOMY SURGICAL PROCEDURE, IT WAS NOTED THAT THE MONOPOLAR CURVED SCISSORS WERE BROKEN AT THE END AND WOULD NOT COME OUT OF THE TROCAR CANNULA. 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
    310566 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M11130607 559

    Patients

    Seq Age Sex Outcome Treatment
    1