BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3112689 · Received May 14, 2013

    Report

    Report Number
    2955842-2013-01660
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 16, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE COMPLAINT THE ORANGE SLEEVE WAS CRACKED WAS CONFIRMED. FOR CLARIFICATION, THE TUBE EXTENSION WAS CRACKED AT THE PROXIMAL CLEVIS INTERFACE. THE CLEVIS WAS DISLODGED FROM THE TUBE EXTENSION AS A RESULT. ENGINEERING CONCLUDED THE TUBE EXTENSION LIKELY BROKE DUE TO EXCESSIVE SIDE LOADING OR OTHER MISHANDLING. ADDITIONAL DAMAGE FOUND WAS DEEP SCRATCHES EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH ON THE DISTAL END OF THE MAIN TUBE. ENGINEERING CONCLUDED THE DAMAGE MAY BE DUE TO MISHANDLING. ELECTRICAL CONTINUITY PASSED. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DEEP SCRATCHES EXHIBITING LIGHT MATERIAL REMOVAL, FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI MYOMECTOMY PROCEDURE THE ORANGE SLEEVE WAS CRACKED ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT AND WAS UNABLE TO BE REMOVED FROM THE TROCAR. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. 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
    213029 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10121206 499

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS & ACCESSORIES ESU