BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 2854851 · Received December 3, 2012

    Report

    Report Number
    3005075853-2012-05431
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 5, 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). ADDITIONAL INFORMATION: THE INSTRUMENT WAS RECEIVED WITH THE ENERGY BUTTON DETACHED AND NOT RETURNED WITH THE INSTRUMENT. THE DEVICE DID NOT OPEN AND CLOSED AS EXPECTED DUE TO THE DETACHED BUTTON. TESTING WITH THE GENERATOR WAS LIMITED BECAUSE OF THE DETACHED BUTTON. THE INSTRUMENT WAS DETECTED BY THE GENERATOR. WITHOUT THE BUTTON THE INSTRUMENT CANNOT BE EASILY ACTIVATED AND CAN PREVENT THE JAWS FROM OPENING AND CLOSING AS EXPECTED. OUR MANUFACTURING PROCESS VERIFIES THE PRESENCE AND FUNCTIONALITY OF THE INSTRUMENT PRIOR TO SHIPPING. NO CONCLUSION COULD BE REACHED AS TO HOW THE BUTTON DETACHED FROM THE INSTRUMENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, THE JAWS WOULD NOT OPEN AND WOULD NOT CLOSE. THE JAWS WOULD NOT GRASP TOGETHER. 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