BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS TIPCOVER ACCESSORY

    MDR report key: 3250819 · Received July 29, 2013

    Report

    Report Number
    2955842-2013-02781
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 26, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON INDICATED THAT ARCING WAS OBSERVED FROM THE MCS TIP COVER ACCESSORY. HOWEVER, AT THIS TIME THERE IS NO EVIDENCE THAT THE PATIENT WAS HARMED OR INJURED BECAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE SURGEON OBSERVED ARCING INVOLVING THE USE OF A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY INSTALLED ON AN MCS INSTRUMENT. ACCORDING TO THE SURGEON, ENERGY WAS SEEN LEAVING THE TIP COVER IN AN ABNORMAL LOCATION. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE REMOVED. THE SURGEON EXAMINED THE TIP COVER AND FOUND A PIN HOLE WITH A BURN MARK. THE MCS TIP COVER ACCESSORY WAS REPLACED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED. THE SITE WAS USING A VALLEY LAB FORCE FX ELECTROSURGICAL UNIT (ESU) WITH A SETTING OF 30. THE SURGICAL PROCEDURE WAS NOT RECORDED. ELECTRO LUBE WAS APPLIED TO THE MCS INSTRUMENT PRIOR TO INSTALLATION OF THE MCS TIP COVER ACCESSORY. DURING THE SURGICAL PROCEDURE, THE MCS INSTRUMENT WAS INSTALLED ON PATIENT SIDE MANIPULATOR 1 (PSM1) AND A PROGRASP FORCEPS INSTRUMENT WAS INSTALLED ON PSM3. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352631 MONOPOLAR CURVED SCISSORS TIPCOVER 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, & ESU