BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 3090680 · Received May 2, 2013

    Report

    Report Number
    2955842-2013-01508
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 3, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT. THE INSTRUMENT WAS CHECKED FOR RECOGNITION ON AN IN-HOUSE IS3000 SYSTEM. THE SYSTEM SUCCESSFULLY RECOGNIZED INSTRUMENT, SHOWING 3 USES LEFT. THE POGO PINS DID NOT STICK AND WERE NOT CONTAMINATED. DCP VERIFICATION OF THE INSTRUMENT PASSED. ENGINEERING WAS UNABLE TO REPLICATE THE RECOGNITION ISSUE. ADDITIONAL OBSERVATIONS NOT REPORTED WAS A FRAYED CABLE AND DAMAGED DISTAL CLEVIS. THE PITCH DOWN CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. THE FRAYED STRANDS STUCK OUT AT THE INSTRUMENTS WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. THE DISTAL CLEVIS HUB EXHIBITED SCRATCH AND GOUGE MARKS ADJACENT TO THE FRAYING. ENGINEERING CONCLUDED THE CLEVIS DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE AND LIKELY CONTRIBUTED TO CABLE FRAYING. NO OTHER DAMAGE FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) 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 PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE THAT THE SYSTEM WOULD NOT RECOGNIZE THE LARGE NEEDLE DRIVER INSTRUMENT. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192048 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-06 M10130201 394

    Patients

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