BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 MM MCS TIP COVER ACCESSORY

    MDR report key: 2974290 · Received February 22, 2013

    Report

    Report Number
    2955842-2013-00602
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 24, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT AND/OR ACCESSORY HAVE NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. INTUITIVE SURGICAL CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED AND/OR POST ENGINEERING ANALYSIS IF THE INSTRUMENT ACCESSORY IS RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE END OF THE TIP COVER BURNED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77712 8 MM MCS TIP COVER ACCESSORY ENDOSCOPIC INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-12

    Patients

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