BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8 MM TIP COVER ACCESSORY

    MDR report key: 2983145 · Received February 28, 2013

    Report

    Report Number
    2955842-2013-00664
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 29, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT AND TIP COVER ACCESSORY HAVE NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. INTUITIVE SURGICAL ATTEMPTED TO CONTACT THE INITIAL REPORTER OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED OR OBTAINED AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE DATE OF EVENT FOR THIS REPORTED COMPLAINT IS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A VIDEO WAS POSTED ON (B)(6) BY DR (B)(6) WITH THE FOLLOWING DESCRIPTION: VIDEO DOCUMENTED INSULATION FAILURE OF ROBOTIC MONOPOLAR HOT SHEAR INSTRUMENT, DURING ROBOTIC ASSISTED HYSTERECTOMY PROCEDURE. INSULATION FAILURE SEEN AS SPARKS, FIRING AGAINST THE POSTERIOR WALL SEROSA OF THE UTERINE CORPUS. THIS IS RELATED TO MALFUNCTION OF THE MONOPOLAR INSTRUMENT (HOT SHEAR) SLEEVE. CAREFUL HANDLING OF THE INSTRUMENT (AND IT'S SHORTCOMINGS) IS A MUST, TO AVOID INJURY TO SURROUNDING STRUCTURES IN THE OPERATIVE FIELD (SUCH AS BOWEL). FREQUENT CHANGE, AS NEEDED, OF THE HOT SHEAR MONOPOLAR INSTRUMENT IS NEED TO AVOID SUCH FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87727 8 MM TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180

    Patients

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