BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 MM MCS TIP COVER ACCESSORY

    MDR report key: 2964877 · Received February 15, 2013

    Report

    Report Number
    2955842-2013-00524
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY WAS NOT RETURNED TO ISI FOR EVALUATION, AS THE INITIAL REPORTER INDICATED THAT THE TIP COVER WAS DISCARDED, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE TIP COVER IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF OBSERVED ARCING FROM THE MCS TIP COVER ACCESSORY INSTALLED ON THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE MCS INSTRUMENT WITH THE TIP COVER INSTALLED WAS REMOVED, AND INSPECTION OF THE TIP COVER BY THE SURGICAL STAFF FOUND THAT THERE WAS A TEAR IN THE MIDDLE AREA OF THE TIP COVER. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A REPLACEMENT TIP COVER ACCESSORY AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67326 8 MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-12

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURG SYS INST., ACCESSORIES AND ESU