BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 2854832 · Received December 3, 2012

    Report

    Report Number
    3005075853-2012-05433
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K112033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4): ADDED ADDITIONAL INFORMATION. THE DEVICE WAS RECEIVED WITH THE CORD CUT OFF.DUE TO THE RETURNED CONDITION, FUNCTIONAL TESTING COULD NOT BE PERFORMED BUT THE DEVICE WAS MECHANICALLY TESTED. NO MECHANICAL ISSUES WERE FOUND. THE JAWS OPENED AND CLOSED NORMALLY. THE JAW WAS INSPECTED AND NOTHING WAS FOUND THAT COULD HAVE IMPACTED THE OPENING AND CLOSING OF THE JAW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLON RESECTION PROCEDURE, THE CASE WAS APPROXIMATELY TWO HOURS AND THROUGHOUT THE CASE THE DEVICE WAS NOT CLEANED THEN THE TWO JAWS WOULD NOT COME TOGETHER. THE JAWS WOULD NOT OPEN AND WOULD NOT CLOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL G2 CURVED JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA J4CD0C

    Patients

    Seq Age Sex Outcome Treatment
    1