BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 2862873 · Received December 10, 2012

    Report

    Report Number
    2955842-2012-01220
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    September 28, 2012
    Report Date
    November 12, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. COMPLAINT NOT RECOGNIZED IS NOT CONFIRMED, HOWEVER FINDING SCRATCHES ON MAINTUBE. DISTAL END OF MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. SUGGESTING THE MAY HAVE BEEN CAUSED BY INSTRUMENT COLLISIONS OR ROUGH HANDLING. EVIDENCE NOT CONCLUSIVE BUT DAMAGE TO MAINTUBE MOST LIKELY DUE TO MISHANDLING. NO OTHER DAMAGE FOUND. THE ACCOUNT WAS CONTACTED TO DETERMINE WHETHER ANY MATERIAL FELL INSIDE THE PATIENT. TO DATE, NO FURTHER INFORMATION HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, THE SURGICAL STAFF REPORTED THAT THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS NOT RECOGNIZED BY THE INSTRUMENT. THE INSTRUMENT WAS RETURNED FOR FAILURE ANALYSIS ON (B)(4) 2012. FAILURE ANALYSIS DETECTED LIGHT MATERIAL REMOVAL FROM THE MAIN TUBE. THE ACCOUNT WAS CONTACTED TO DETERMINE WHETHER ANY MATERIAL FELL INSIDE THE PATIENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120316 486

    Patients

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