BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3981189 · Received August 5, 2014

    Report

    Report Number
    2955842-2014-04723
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 7, 2014
    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. FAILURE ANALYSIS PLACED THE INSTRUMENT ON AN IN-HOUSE SYSTEM AND THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT TESTING. THE INSTRUMENT FAILED THE CUT TEST AS THE SCISSORS DID NOT CUT CLEANLY THROUGH (B)(4) LATEX. THE LATEX WAS SNAGGED AT THE SCISSOR TIPS. THE BLADE EDGES WERE UNDAMAGED, BUT THE EDGES EXHIBITED WEAR AT THE TIPS, NEGATIVELY AFFECTING CUT PERFORMANCE. THE INSTRUMENT PASSED ENERGY AND ELECTRICAL CONTINUITY TESTING. FAILURE ANALYSIS ALSO OBSERVED THAT THE DISTAL END OF THE MAIN TUBE EXHIBITED HAIRLINE CRACKS IN THE AXIAL DIRECTION. THE EVIDENCE WAS INCONCLUSIVE, BUT THE HAIRLINE CRACKS WERE LIKELY DUE TO MISHANDLING/MISUSE. 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. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE MICROCRACKS, 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 THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT DID NOT WORK DURING A DA VINCI SURGICAL PROCEDURE. NO FRAGMENTS FELL INTO THE 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
    457673 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10111111 278

    Patients

    Seq Age Sex Outcome Treatment
    1