BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEAL SUPER JAW

    MDR report key: 2819231 · Received November 5, 2012

    Report

    Report Number
    3005075853-2012-05014
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 12, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED FOR ANALYSIS SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION FROM SALES REP. SURGEON IS UROLOGIST; NORMALLY DOESN'T USE ENERGY, IS A CCT; HAS TRIALED CON-MED DEVICE AND LIGASURE; 1ST TIME USING SUPER JAW IN OR; FIRST TIME WORKING WITH THE SALES REP IN OR; HAD ONE OFFICE VISIT PRIOR TO PROCEDURE (WITH CHICKEN SKIN) AND A REVIEW OF STEPS FOR USE RIGHT BEFORE PROCEDURE; HOSPITAL GIVES SURGEONS DEVICES REQUESTED. CASE PERSPECTIVE FROM SALES REP: BEEN IN HOSPITAL FOR 5-6 MONTHS; SURGEON WAS TAKING DOWN THE SUPERIOR ATTACHMENT OF THE RIGHT ADRENAL GLAND (CLOSE TO THE VENA CAVA); INSTRUMENT WAS PUT DOWN AND IMMEDIATELY THE VENA CAVE WAS BLEEDING. SURGEON COMMENTED THAT THE INFERIOR VENA CAVA APPEARED 'CUT' (AS IF BY A BLADE). SURGEON ASKED IF ELECTRICITY COULD JUMP AND DAMAGE THE VESSEL? SALES REP SAID IF YOU WERE <1MM. SURGEON ASKED IF THE KNIFE WAS ABLE TO GO OUTSIDE THE JAWS? SALES REP SAID NO AS PART OF THE DESIGN. AFTER 2 HOURS OF TRYING TO REPAIR THE INFERIOR VENA CAVA THE VASCULAR SURGEON WAS CONTACTED. SALES REP THINKS THAT THE CONVEX SIDE OF THE JAW WAS TOWARD THE VENA CAVA. SURGEON DID NOT APPEAR TO BE STRUGGLING WITH FTF. TECHNIQUE USED WAS SAME FOR ALL THREE FIRINGS, CLOSE ON TISSUE, ACTIVATE, WAIT UNTIL SECOND TONE (EVEN THOUGH HE WAS INSTRUCTED TO ADVANCE BEFORE THEN), SLOWLY ADVANCE AND WAIT FOR FINAL TONE. SURGEON COMMENTED THAT HE MAY HAVE BEEN TOO 'AGGRESSIVE' WITH THE DEVICE; TOO CLOSE TO THE SURROUNDING STRUCTURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN RIGHT NEPHRECTOMY PROCEDURE, ON THE THIRD FIRING OF THE DEVICE, THE SURGEON ACTIVATED THE DEVICE ON TISSUE RIGHT NEXT TO THE VENA CAVA, WHICH CAUSED DAMAGE TO THE VENA CAVA. THE SURGEON COULD NOT CONTROL THE BLEEDING OR MEND THE VENA CAVA. THE SURGEON CONTINUED TO USE THE SUPERJAW WHEN NEEDED BUT THE VASCULAR SURGEON WAS CALLED IN TO COMPLETE THE CASE WITH HIM. THE PATIENT BLED PROFUSELY AND WAS GIVEN 15 UNITS OF BLOOD AND 16 UNITS OF PLASMA TO KEEP HIM ALIVE. HE IS IN STABLE CONDITION AT THIS TIME. ONE DEVICE WAS DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR