BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CAUTERY INSTRUMENT

    MDR report key: 3002961 · Received March 13, 2013

    Report

    Report Number
    2955842-2013-00812
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 11, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. 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 DURING A DA VINCI SI SINGLE SITE SURGICAL PROCEDURE, THE SURGICAL TECHNICIAN EXPERIENCED DIFFICULTY REMOVING THE A-SURE CAUTERY HOOK ACCESSORY INSTALLED ON THE MONOPOLAR CAUTERY INSTRUMENT, CAUSING THE TIP OF THE MONOPOLAR CAUTERY INSTRUMENT TO BREAK. NO MISSING OR FALLEN PIECES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104844 MONOPOLAR CAUTERY INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 428052-06 S10121024 946

    Patients

    Seq Age Sex Outcome Treatment
    1 DAV SI SURG. SYS., MONOPOLAR CAUTERY INST., & ESU