BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3130936 · Received May 24, 2013

    Report

    Report Number
    2955842-2013-01852
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 27, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE CUSTOMER REPORTED FAILURE MODE WITH THE FOLLOWING CLARIFICATION THAT THE INSTRUMENT HAD A BROKEN GRIP CABLE MAKING IT INCAPABLE OF PROPER MOVEMENT. ONE GRIP CABLE WAS BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND WAS NOT DAMAGED. THE CABLE SEGMENT WAS STICKING OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. THE INSTRUMENT ALSO PASSED ELECTRICAL CONTINUITY TESTING. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; MAIN TUBE CRACK FOUND DURING THE FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR. 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, IT WAS NOT POSSIBLE TO MOVE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. REPORTEDLY, THE BOWDEN WAS TORN. NO MISSING OR FALLEN PIECES WERE 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
    231488 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 400179-10 M10121008 114

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SURG. SYS., INSTRUMENTS AND ACCESSORIES.