BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 2013314 · Received March 10, 2011

    Report

    Report Number
    2955842-2011-00067
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 9, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY HAS NOT BEEN RETURNED FOR EVALUATION, HOWEVER, THE MONOPOLAR CURVED SCISSORS INSTRUMENT USED WITH THE TIP COVER DURING THE PROCEDURE WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING FOUND NO CHAR MARKS OR SIGNS OF ARCING ON THE INSTRUMENT. ELECTRICAL CONTINUITY PASSED AND NO DAMAGE WAS FOUND. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, WHILE USING THE MONOPOLAR CURVED SCISSORS INSTRUMENT WITH THE TIP COVER ACCESSORY INSTALLED, ARCING WAS OBSERVED. NO PATIENT INJURY, HARM OR ADVERSE OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-10 C10344

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR DA VINCI S SYSTEM, INSTRUMENTS, ACCESSORIES, & ES