BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1850641 · Received October 1, 2010

    Report

    Report Number
    2955842-2010-00418
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    NURSE

    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 MEDWATCH REPORT WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST-EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ON (B)(6) 2010, THE INITIAL REPORTER INFORMED INTUITIVE SURGICAL THAT NO POST-SURGICAL COMPLICATIONS WERE EXPERIENCED BY THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, ONE OF THE BLADES FROM THE MONOPOLAR CURVED SCISSORS INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT. THE PROCEDURE WAS EXTENDED 3.5 HOURS DUE TO THE TIME SPENT BY THE SURGICAL STAFF LOOKING FOR THE BROKEN BLADE. A GEL PORT WAS ADDED AND A PORT INCISION WAS EXTENDED IN ORDER TO INSPECT THE PATIENT'S BOWEL AND REMOVE THE BROKEN BLADE. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-09 M10091123

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention DA VINCI S SYSTEM, ACCESSORIES & ESU