BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 STRAIGHT JAW

    MDR report key: 3172484 · Received June 17, 2013

    Report

    Report Number
    3005075853-2013-03047
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 10, 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 Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 WITH THE UPPER JAW MISSING AND RETURNED. THE DEVICE WAS TESTED WITH A GENERATOR AND THE DEVICE PERFORMED AS REQUIRED DURING TESTING; THOUGH ALL TESTING COULD NOT BE COMPLETED DUE TO THE MISSING TOP JAW. HOWEVER; NO YELLOW ALERT SCREENS WERE DISPLAYING DURING TESTING. THERE IS INSUFFICIENT EVIDENCE RELATED TO WHAT CAUSED THE DAMAGE; A PROBABLE CAUSE OF THE DAMAGE TO THE JAWS 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 ASSISTED VAGINAL HYSTERECTOMY, THE TOP JAW OF THE DEVICE BROKE OFF. THE TISSUE WAS NORMAL THICKNESS AND THE SURGEON WAS USING THE DEVICE AS INTENDED. THE GENERATOR GAVE AN ERROR TONE ¿REPLACE DEVICE.¿ THE BROKEN JAW WAS RETRIEVED FROM THE PATIENT USING FLUOROSCOPY. THE CASE WAS COMPLETED USING A VAGINAL APPROACH. NO PATIENT CONSEQUENCES WERE REPORTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ONE DEVICE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273290 ENSEAL G2 STRAIGHT JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK K4CH2M

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR