BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3143576 · Received June 3, 2013

    Report

    Report Number
    2955842-2013-01965
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 6, 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
    PA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE INSTRUMENT WAS PLACED ON SYSTEM FOR LATEX CUT TEST AND THE SCISSORS DID NOT CUT CLEANLY THROUGH .006 LATEX. THE LATEX WAS SNAGGED AT THE SCISSOR TIPS. THE BLADE EDGES WERE UNDAMAGED, BUT EDGES EXHIBITED WEAR AT THE TIPS, NEGATIVELY AFFECTING CUT PERFORMANCE. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. DEEP SCRATCHES NEAR THE DISTAL TIP OF THE INSTRUMENT APPROXIMATELY 0.8 FROM THE BASE OF THE TUBE EXTENSION. ADDITIONAL OBSERVATION THAT WAS NOT REPORTED BY THE CUSTOMER WAS MICRO-CRACKS FOUND AT THE DISTAL END OF THE TUBE. THE MICRO-CRACKS RUN IN THE AXIAL DIRECTION. 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 THESE IS CONFINED TO 2CM OF THE DISTAL END OF THE INSTRUMENT SHAFT. 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 A DA VINCI SI GASTRIC BYPASS PROCEDURE THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS NOTED TO BE DULL. 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
    245152 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10121126 470

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES