BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3203414 · Received July 2, 2013

    Report

    Report Number
    2955842-2013-02397
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 5, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND WITH A PIECE OF THE YAW PULLEY BROKEN OFF THE YAW PULLEY, WHICH EXPOSED THE CABLE AND THE CABLE CRIMP. THE CONDUCTOR WIRE WAS ALSO FOUND BROKEN. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTABLE MALFUNCTION, IF TO REOCCUR, COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, THE USER FACILITY IDENTIFIED AN ISSUE WITH A FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE INSTRUMENT GOES TO A RIGHT ANGLE AND CAN'T BE MOVED THE OTHER DIRECTION. NOTHING REPORTEDLY FELL INTO A PATIENT. 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
    301184 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M20111101 117

    Patients

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