BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3083707 · Received April 29, 2013

    Report

    Report Number
    2955842-2013-01446
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    November 9, 2012
    Report Date
    April 2, 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 HOUSING END POGO PINS WERE CORRODED AROUND THE PINS AND ONE PIN WAS STUCK. DUE TO THE CORROSION, THE POGO PIN WAS JAMMED DOWN. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. ENGINEERING CONCLUDED THE DAMAGE WAS MOST LIKELY DUE TO IMPROPER CLEANING. ENGINEERING ALSO FOUND CORROSION AROUND THE CLAMPING PULLEYS WITH THE RESIDUE COVERED UP THE CABLES CREATED STIFFNESS TO THE CABLE MOVEMENT. ENGINEERING CONCLUDED THIS WAS MOST LIKELY DUE TO IMPROPER CLEANING. ENGINEERING ALSO FOUND AN ORANGE RUSTY LIKE SUBSTANCE AROUND THE BEARINGS. THIS MOST LIKELY WAS DUE TO IMPROPER CLEANING. ENGINEERING ALSO FOUND THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS SHOWING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. ENGINEERING CONCLUDED THE DAMAGE WAS LIKELY DUE TO MISHANDLING. 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 A DA VINCI S CYSTECTOMY PROCEDURE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS NOT RECOGNIZED BY THE SYSTEM. THE INSTRUMENT WAS EXCHANGED INTO A BACKUP INSTRUMENT. 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
    183480 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M11111128 461

    Patients

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