BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3062074 · Received April 16, 2013

    Report

    Report Number
    2955842-2013-01261
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    January 22, 2013
    Report Date
    March 18, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE ONE GRIP CLOSE CABLE WAS BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND WAS NOT DAMAGED. THE CABLE SEGMENT STUCK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. NO OTHER DAMAGE WAS FOUND. ENGINEERING ALSO FOUND PRINT REMOVED FROM EXTENSION TUBE. ENGINEERING CONCLUDED THE DAMAGE WAS LIKELY DUE TO IMPROPER CLEANING. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE DAMAGE TO THE INSTRUMENT'S PAD PRINTING, 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 PROSTATECTOMY PROCEDURE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS NOTED TO HAVE A BROKEN CABLE NEAR THE TIP OF THE INSTRUMENT. THE TIP COVER WAS NOT DAMAGED. THE INSTRUMENT WAS REMOVED AND REPLACED. 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
    163580 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M11120517 223

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES