BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 2072730 · Received April 29, 2011

    Report

    Report Number
    2955842-2011-00128
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K002489
    Removal / Correction Number
    2955842-051613-005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED FOR RETROSPECTIVE ACTIVITY PERFORMED RELATING TO FIELD ACTION NUMBER 2955842-051613-005 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 2 CM 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 FOUND A SEGMENT OF THE RIGHT BLADE TO BE BROKEN OFF FROM THE INSTRUMENT. THE BROKEN PIECE WAS NOT RETURNED. THE BLADE FRACTURED AT THE CROSS SECTION OF THE GRIP CABLE CRIMP AND HALF OF THE CABLE CRIMP IS EXPOSED. THE FRACTURED PLANE OF THE BLADE IS NEARLY STRAIGHT. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, THE 'JAW' OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT PARTIALLY BROKE AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A REPLACEMENT INSTRUMENT OF THE SAME TYPE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-09 M10091119 916

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM, INSTRUMENTS, ACCESSORIES, & ES