BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3183220 · Received June 21, 2013

    Report

    Report Number
    2955842-2013-02268
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 17, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THERE WAS A CRACKED TUBE EXTENSION (ORANGE PORTION OF THE INSTRUMENT) AT THE PROXIMAL CLEVIS INTERFACE. THE CLEVIS WAS DISLODGED FROM THE TUBE EXTENSION. ELECTRICAL CONTINUITY TESTING PASSED. ADDITIONAL OBSERVATION NOT REPORTED BY THE CUSTOMER WAS MAIN TUBE DAMAGE. THE MAIN TUBE HAD DEEP SCRATCHES AT THE DISTAL END OF THE MAIN TUBE, APPROXIMATELY 2.4 IN LENGTH. EVIDENCE NOT CONCLUSIVE, BUT TUBE EXTENSION DAMAGE WAS LIKELY DUE TO EXCESSIVE LOADING OR OTHER MISHANDLING. THE OBSERVED MAIN TUBE DAMAGE WAS ALSO LIKELY DUE TO MISHANDLING. THE INSTRUMENTS & ACCESSORIES 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. THE CUSTOMER REPORTED COMPLAINT (CRACKED TUBE EXTENSION) DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT. THE CLINICAL RISK EVALUATION PERFORMED ON THE HEALTH HAZARD ASSESSMENT DATED (B)(4) 2013 FOR THE MONOPOLAR CURVED SCISSORS STATES: IN A FRAGMENT-CAUSING FAILURE (SUCH AS A CABLE FAILURE, A CRIMP SEPARATING FROM A CABLE, ETC) FOR THE MCS INSTRUMENT THE TIP COVER ACCESSORY WILL HOLD SUCH FRAGMENTS INSIDE THE TIP COVER, PREVENTING LOSS INTO THE PATIENT DURING THE REMOVAL OF THE INSTRUMENT. BECAUSE THE TIP COVER ACTS AS A BARRIER, THESE FAILURES, WHICH MIGHT BE REPORTABLE IN OTHER INSTRUMENTS, ARE NOT REPORTABLE EVENTS FOR THE MCS INSTRUMENT. HOWEVER, THE MAIN TUBE SCRATCHES 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 USER FACILITY IDENTIFIED A CRACKED ORANGE PEEL ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT AND IT STOPPED WORKING. 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
    282557 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M11130208 156

    Patients

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