BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8 MM MCS TIP COVER ACCESSORY

    MDR report key: 2893714 · Received January 2, 2013

    Report

    Report Number
    2955842-2013-00006
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT TO REQUEST MORE INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. THE MCS TIP COVER WAS DISCARDED AND IT WAS NOT RETURNED FOR EVALUATION, THE CAUSE OF THE DAMAGE TO THE TIP COVER PRIOR TO THE REPORTED ARCING EVENT IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, MD SURGEON DR. (B)(6) REPORTED, DURING A TOUGH CASE WITH EXTREME ANGULATION, A BREAK IN THE MCS TIP COVER WAS SEEN. THIS RESULTED IN A SLIGHT BURN TO THE UTERUS. THE TIP COVER WAS DISCARDED AFTER THE CASE. IT WAS A FOUR HOUR CASE FOR NODE DEBUNKING/REMOVAL ON A HIGH BMI ((B)(6)) PATIENT WITH A (B)(6) SIZE UTERUS. SETUP WAS A MARYLAND IN ARM 2, MCS (MONOPOLAR CURVED SCISSORS) INSTRUMENT IN ARM 1, AND PROGRASP IN ARM 3 ON SAME SIDE AS ARM MOST OF THE TIME SURGEON WAS DEEP IN THE PELVIS, PERFORMING FINE DISSECTION WITH FEW LARGE MOVEMENTS. SURGEON WAS THOROUGHLY ARTICULATING THE MCS INSTRUMENT AND REGULARLY USED IT TO RETRACT THE UTERUS. DAVINCI ROBOT SYSTEM SETTINGS WERE AT 30/30 AND THE MCS TIP COVER ARCED TO THE UTERUS ABOUT THREE HOURS INTO THE CASE. THE SURGICAL STAFF REPLACED THE MCS TIP COVER (SAME INSTRUMENT) AND HAD NO FURTHER PROBLEMS FOR THE REMAINING HOUR OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603 8 MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-12

    Patients

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