BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3083726 · Received April 29, 2013

    Report

    Report Number
    2955842-2013-01453
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Removal / Correction Number
    2955842-051613-005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED FOR RETROSPECTIVE ACTIVITY PERFORMED RELATING TO FIELD ACTION NUMBER (B)(4) TO INVESTIGATE MICRO-CRACKS ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT. THESE TYPES OF MICRO-CRACKS WILL NOT LEAD TO MECHANICAL FAILURE OF THE INSTRUMENT; HOWEVER, THERE IS A POTENTIAL FOR INSULATION FAILURE AFTER REPROCESSING, RESULTING IN A PATHWAY FOR ELECTROSURGICAL ENERGY TO LEAK TO TISSUE AND POTENTIALLY CAUSE UNINTENDED INJURIES. THE LOCATION OF THESES MICRO-CRACKS IS CONFINED TO (B)(4) OF THE DISTAL END OF THE INSTRUMENT SHAFT. THIS INSTRUMENT WAS INSPECTED AS PART OF THIS RETROSPECTIVE ACTIVITY AND FOUND TO CONTAIN CRACKS ON THE INSTRUMENT MAIN TUBE.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE TUBE EXTENSION WAS BROKEN AND MISSING A PIECE AT THE PROXIMAL CLEVIS INTERFACE. THE MISSING PIECE MEASURED ROUGHLY ABOUT 0.267 X 0.253. THE CLEVIS WAS DISLODGED FROM THE TUBE EXTENSION. THE TUBE EXTENSION LIKELY BROKE DUE TO EXCESSIVE SIDE LOADING. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. ENGINEERING ALSO FOUND SCRATCHES ON THE SURFACE OF THE DISTAL PULLEY. INSULATION DAMAGE WAS FOUND ON THE MAIN TUBE BY THE EXTENSION TUBE SIDE. THE LENGTH OF THE DAMAGE MEASURED ABOUT 0.202. THE INSTRUMENTS AND ACCESSORIES USER MANUAL 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 DAMAGE TO THE INSTRUMENT'S MAIN TUBE, WHICH WAS 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 REPROCESSING THE DA VINCI S SURGICAL MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ORANGE PART AT THE END OF THE INSTRUMENT WAS NOTED TO HAVE FALLEN APART. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185399 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M11130112 792

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI S SYSTEM, ESU, INSTRUMENTS & ACCESSORIES