BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 MM MCS TIP COVER ACCESSORY

    MDR report key: 3081313 · Received April 26, 2013

    Report

    Report Number
    2955842-2013-01419
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 1, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER 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 ACCESSORY IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE DISTRIBUTOR TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE MCS TIP COVER ACCESSORY WAS NOT AVAILABLE FOR RETURN TO ISI FOR EVALUATION. THE DISTRIBUTOR INDICATED THAT THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE AND WAS INSTALLED ON THE MCS INSTRUMENT USING THE INSTALLATION TOOL. THE DISTRIBUTOR WAS UNABLE TO INDICATE IF ELECTROLUBE WAS APPLIED TO THE MCS INSTRUMENT PRIOR TO INSTALLATION OF THE MCS TIP COVER ACCESSORY. THE CANNULA WAS INSPECTED WITH A PIN GAGE PRIOR TO USE. THE DISTRIBUTOR WAS UNABLE TO PROVIDE THE ELECTROSURGICAL GENERATOR UNIT (ESU) SETTINGS USED DURING THE REPORTED SURGICAL PROCEDURE. THE DISTRIBUTOR INDICATED THAT THE MCS INSTRUMENT COLLIDED WITH ANOTHER INSTRUMENT DURING THE SURGICAL PROCEDURE. HOWEVER, THE DISTRIBUTOR WAS UNABLE TO PROVIDE DETAILS OF THE DAMAGE FOUND ON THE MCS TIP COVER ACCESSORY. THE DISTRIBUTOR INDICATED THAT THE SURGICAL PROCEDURE WAS RECORDED. HOWEVER, THE DISTRIBUTOR DECLINED TO PROVIDE A COPY OF THE VIDEO TO ISI FOR EVALUATION. THE DISTRIBUTOR DENIED THAT THE PATIENT SUSTAINED ANY INJURIES OR COMPLICATIONS BECAUSE OF THE REPORTED MCS TIP COVER ACCESSORY ISSUE. THE DISTRIBUTOR INDICATED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH NO REPORTED PROBLEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, THE SURGEON OBSERVED A SPARK COMING FROM THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY INSTALLED ON THE MCS INSTRUMENT. EXAMINATION OF THE MCS TIP COVER ACCESSORY BY THE SURGICAL STAFF FOUND AN UNSPECIFIED BROKEN PORTION. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A REPLACEMENT MCS TIP COVER ACCESSORY AND WITHOUT ANY OTHER PROBLEMS. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182587 8 MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-10

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SURG SYS INST., ACCESSORIES, & ESU