BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 STRAIGHT JAW

    MDR report key: 3050676 · Received April 10, 2013

    Report

    Report Number
    3005075853-2013-01695
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 26, 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
    NL
    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 RECEIVED WITH THE TOP OF THE I-BLADE FRACTURED AND LIFTED. IN ADDITION THE JAW WAS FOUND DETACH FROM INSTRUMENT AND NOT RETURNED. THE DEVICE WAS PARTIALLY TESTED WITH A GENERATOR AND THE DEVICE PERFORMED AS REQUIRED DURING TESTING; THOUGH ALL TESTING COULD NOT BE COMPLETED DUE TO THE DAMAGED TOP JAW AND I BLADE. AS REPORTED IN THE EVENT DESCRIPTION IT IS LIKELY THAT THE DAMAGE TO THE JAW AND I-BLADE WAS CAUSED BY NOT ALLOWING THICK AND FIBROUS TISSUES TO DENATURE PRIOR TO I-BLADE ADVANCEMENT OR ATTEMPTING TO CUT THROUGH THICK DENSE TISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE THE GYNECOLOGIST TRIED TO DISSECT/CUT A PORTION OF THE WALL OF THE CERVIX. THE TISSUE WAS IN FACT VERY THICK/DENSE AND WHILE CUTTING AND COAGULATING THE JAW OF THE INSTRUMENT BROKE OFF. THE DOCTOR ADMITTED THE CAUSE WAS LIKELY DUE TO THE FACT THAT THE TISSUE WAS PROBABLY TOO THICK BUT SHE WANTED TO SEE THE LIMITS OF THE INSTRUMENT. WE WANT TO REPORT THIS BECAUSE A TOTAL BREAKAGE OF THE JAWS IS NOT VERY NORMAL. NO PATIENT CONSEQUENCES. PROCEDURE WAS COMPLETED WITH USE OF A MONOPOLAR DEVICE. ONE DEVICE WILL BE RETURNING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153485 ENSEAL G2 STRAIGHT JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK K4C64N

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR