BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPSINSTRUMENT

    MDR report key: 2944463 · Received February 5, 2013

    Report

    Report Number
    2955842-2013-00369
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    August 31, 2012
    Report Date
    January 7, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE ALLEGED COMPLAINT THAT THE INSTRUMENT HAD A FAULTY WRIST MOVEMENT ISSUE COULD NOT BE CONFIRMED. THE INSTRUMENT WAS PLACED ON AN IS3000 SYSTEM AND DRIVEN. RECOGNITION AND ENGAGEMENT OF THE INSTRUMENT PASSED. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE INSTRUMENT GRIPS OPENED AND CLOSED PROPERLY. FUNCTIONAL PERFORMANCE TESTING OF THE INSTRUMENT DID NOT FIND ANY ISSUES. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS TUBE DAMAGE. THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .070 - .120 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THAT THE DAMAGE MIGHT HAVE BEEN CAUSED BY MISHANDLING/MISUSE. NO OTHER INSTRUMENT DAMAGE WAS FOUND. 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 REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF ALLEGED THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD A FAULTY WRIST MOVEMENT ISSUE. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED USING AN ALTERNATIVE REPLACEMENT INSTRUMENT AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48600 MARYLAND BIPOLAR FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10120411 724

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SURGICAL SYSTEM, ACCESSORIES, AND ESU