BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3052975 · Received April 11, 2013

    Report

    Report Number
    2955842-2013-01199
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 13, 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. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONFIRMED THE LOOSE CABLE. THE BIPOLAR INSERT WAS MISSING FROM THE BACK END. THE PINS AND CONDUCTOR WIRES WERE STICKING OUT OF THE CHASSIS. THE INSERT MAY HAVE NOT BEEN FULLY SEATED IN THE CHASSIS OR MAY BEEN PULLED OUT WHEN BIPOLAR CORD WAS REMOVED. SOME BIPOLAR CORDS ARE A TIGHT FIT ON THE BIPOLAR PINS AND MAY REQUIRE A HIGH REMOVAL FORCE, POTENTIALLY CAUSING THE INSERT TO PULL OUT. ELECTRICAL CONTINUITY TEST PASSED. AN ADDITIONAL FINDING WAS VARIOUS SCRATCHES ON THE MAIN TUBE SHOWING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. ENGINEERING CONCLUDED THE DAMAGE MAY BE DUE TO MISHANDLING. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS O HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. O 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 AFTER A DA VINCI SURGICAL PROCEDURE THE CABLE BECAME LOOSE ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. THERE WERE NO MISSING PIECES OR FALLEN PIECES 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
    156364 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 400172-08 M10121123 002

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SYSTEM INSTRUMENTS & ACCESSORIES ESU