BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3163646 · Received June 11, 2013

    Report

    Report Number
    2955842-2013-02111
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 20, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT. DURING A DA VINCI S PROSTATECTOMY PROCEDURE THE SURGEON FELT A DISCOMFORT OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT ON 1-ARM. THE SURGEON COULD NOT MOVE THE WRIST OF THE INSTRUMENT. FAILURE ANALYSIS WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE INSTRUMENT WAS EXPIRED BUT FAILURE ANALYSIS WAS ABLE TO ARTICULATE EACH AXIS BY HAND WITHOUT FRICTION. THE HOUSING WAS REMOVED AND THE CABLES WERE INTACT AND NO RESIDUE WAS FOUND AROUND THE GROOVES OF EACH CLAMPING PULLEY. ADDITIONAL OBSERVATION THAT WAS NOT REPORTED BY THE CUSTOMER WERE 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 INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. NO OTHER DAMAGE WAS FOUND. 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 S PROSTATECTOMY PROCEDURE USING THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT THE SURGEON FELT A DISCOMFORT OF THE INSTRUMENT ON 1-ARM. THE SURGEON COULD NOT MOVE THE WRIST OF THE INSTRUMENT. THE SURGICAL STAFF TRIED TO RESEAT THE INSTRUMENT AND THE STERILE ADAPTER, HOWEVER, THE PROBLEM PERSISTED. THE STAFF EXCHANGED IT INTO A BACKUP INSTRUMENT, AND THE PLANNED PROCEDURE WAS COMPLETED WITHOUT PROBLEM. 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
    264275 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10120918 172

    Patients

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