BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPSINSTRUMENT

    MDR report key: 2942712 · Received February 4, 2013

    Report

    Report Number
    2955842-2013-00360
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 8, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE ALLEGED COMPLAINT OF NON-REAL FLUID MOVEMENT WAS CONFIRMED. THE PITCH CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARK. ADDITIONAL FINDING: SCRATCHES WERE FOUND ON THE INSTRUMENT'S MAIN TUBE. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE SHORT IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS, SUGGESTING THE DAMAGE MIGHT HAVE BEEN CAUSED BY INSTRUMENT COLLISIONS OR ROUGH HANDLING. 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 SI SURGICAL PROCEDURE, THE SURGICAL STAFF ALLEGED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD NON-REAL FLUID MOVEMENT. THERE WERE NO MISSING 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
    46016 FENESTRATED BIPOLAR FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10120524 821

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES