BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3078652 · Received April 25, 2013

    Report

    Report Number
    2955842-2013-01394
    Event Type
    Malfunction
    Date Received
    April 25, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 29, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT THAT THE JAWS WOULD NOT CLOSE CORRECTLY. ENGINEERING FOUND NO DAMAGE TO THE GRIPS UPON VISUAL INSPECTION. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND DRIVEN, RECOGNITION AND ENGAGEMENT TESTING PASSED. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. ENGINEERING FOUND MAIN TUBE DAMAGE AND A FRAYED CABLE. THE INSTRUMENT HAD VARIOUS SCRATCH MARKS ON THE DISTAL END OF THE MAIN TUBE SHOWING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .070 - .190 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THE DAMAGE WAS LIKELY CAUSED BY MISHANDLING/MISUSE. THE PITCH DOWN CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. THE FRAYED STRANDS STUCK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. NO OTHER 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 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 REPROCESSING THE DA VINCI S SURGICAL FENESTRATED BIPOLAR INSTRUMENT JAWS WERE NOTED NOT TO CLOSE PROPERLY. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180255 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10130205 539

    Patients

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