BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 STRAIGHT JAW

    MDR report key: 3070757 · Received April 22, 2013

    Report

    Report Number
    3005075853-2013-01891
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K112033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL, ACTIVATING WHEN EACH OF THE MAX AND MIN ACTIVATION BUTTONS WERE DEPRESSED, BUT NO CONTINUOUS ACTIVATION OCCURRED DURING ANY FUNCTIONAL TESTING. THE DEVICE WAS DISASSEMBLED BUT NO ANOMALIES THAT COULD AFFECT THE FUNCTIONALITY OF THE HAND ACTIVATION BUTTONS WERE FOUND. IT COULD NOT BE DETERMINED WHY REPORTEDLY THE DEVICE KEPT BEING ACTIVATED AFTER RELEASING THE ACTIVATION BUTTONS. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY PROCEDURE THERE WAS A BLADE BROKEN, IT COULD BE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171164 ENSEAL G2 STRAIGHT JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK K4C845

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR