BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 2083910 · Received May 11, 2011

    Report

    Report Number
    2955842-2011-00143
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K012833
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VIDEO RECORDING OF THE PROCEDURE WAS REVIEWED BY AN INTUITIVE SURGICAL CLINICAL SALES REPRESENTATIVE AND THE CONSOLE SURGEON. THE VIDEO REVEALED THAT THE SURGEON INADVERTENTLY GRASPED THE PATIENT'S RIGHT ILIAC VEIN WITH A MARYLAND BIPOLAR FORCEPS INSTRUMENT. IT IS THE SURGEON'S BELIEF THAT THIS ACTION CAUSED THE DAMAGE TO THE PATIENT'S VEIN. NO ISSUES WERE OBSERVED WITH THE MARYLAND BIPOLAR FORCEPS INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DISSECTING THE RIGHT SIDE "LYMPHECTOMY" DURING A DA VINCI S HYSTERECTOMY PROCEDURE A TEAR WAS NOTICED HALFWAY THROUGH THE PATIENT'S RIGHT ILIAC VEIN. THE VEIN WAS REPAIRED LAPAROSCOPICALLY USING 12 CLIPS AND FLOSEAL. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND IT WAS REPORTED THAT NO POSTOPERATIVE COMPLICATIONS HAVE BEEN EXPERIENCED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M0110222 166

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SYSTEM, ACCESSORIES & ESU