BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 STRAIGHT JAW

    MDR report key: 3071184 · Received April 22, 2013

    Report

    Report Number
    3005075853-2013-01904
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE UPPER JAW MISSING AND NOT RETURNED. VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED AND EVIDENCE OF SCUFF MARKS ON THE I-BLADE WAS NOTED. 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. THE ¿REPOSITION JAWS AND REACTIVE¿ YELLOW MESSAGE SCREEN IS ADVISING THAT THE INSTRUMENT IS BEING ACTIVATED ON LOW IMPEDANCE (THIN) TISSUE OR METAL (SUCH AS STAPLES, CLIPS, RETRACTORS, OR CLAMPS). HOWEVER, NO YELLOW ALERT SCREENS WERE DISPLAYING DURING TESTING. IT IS LIKELY THAT CUTTING ACROSS A THICK TISSUE BUNDLE COULD HAVE CAUSED THE DAMAGE TO THE I-BLADE AND THE DETACHING OF THE UPPER JAW. ANOTHER PROBABLE CAUSE OF THE DAMAGE TO THE JAWS COULD BE NOT ALLOWING THICK AND FIBROUS TISSUES TO DENATURE PRIOR TO I-BLADE ADVANCEMENT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE THE SURGEON WAS ACTIVATING THE DEVICE ACROSS A THICK BUNDLE OF TISSUE TRYING TO GAIN HEMOSTASIS AND THE GENERATOR ALERTED "REPOSITION JAWS AND REACTIVATE." HE TRIED TO OPEN THE JAW OF THE DEVICE AND IT WOULD NOT OPEN. HE WAS TRYING TO PRY THE JAWS OPEN WITH A HOOK OUTSIDE OF THE PATIENT AND THE JAW BROKE AND THE PTC PORTION FELL OFF OF THE JAW AFTER HE TRIED TO FORCE IT OPEN MANUALLY. NO PIECE FELL INTO THE PATIENT; THE PIECE IS IN THE PACKAGE WITH THE DEVICE. HE THEN USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. DEVICE IS RETURNING FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172822 ENSEAL G2 STRAIGHT JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR