BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 STRAIGHT JAW

    MDR report key: 2854862 · Received December 3, 2012

    Report

    Report Number
    3005075853-2012-05432
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 13, 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
    MN, 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 INSTRUMENT WAS RECEIVED WITH THE UPPER JAW DETACHED AND THE I-BLADE CRACKED. THE UPPER JAW WAS NOT RETURNED WITH THE INSTRUMENT. THE INSTRUMENT WAS TESTED ELECTRICALLY AND IT ACTIVATED AS EXPECTED WHEN CONNECTED TO THE GENERATOR. DUE TO THE RETURNED CONDITION OF THE INSTRUMENT NOT ALL TESTING COULD BE PERFORMED.THERE IS INSUFFICIENT EVIDENCE RELATED TO WHAT CAUSED THE DAMAGE; A PROBABLE CAUSE OF THE DAMAGE TO THE JAWS/I-BLADE COULD BE NOT ALLOWING THICK AND FIBROUS TISSUES TO DENATURE PRIOR TO I-BLADE ADVANCEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHEN THE DEVICE WAS USED FOR THE THIRD BITE THE TOP JAW CAME OFF. THEY OPENED A SECOND DEVICE, RETRIEVED THE TOP JAW. THE PROCEDURE WAS COMPLETED WITH THE SECOND DEVICE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL G2 STRAIGHT JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA J4C20A

    Patients

    Seq Age Sex Outcome Treatment
    1