BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSEAL

    MDR report key: 2002756 · Received February 28, 2011

    Report

    Report Number
    3005075853-2011-00771
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUCTIONS FOR USE STATE: UNDER OPERATION: "GRASP ONLY AS MUCH TISSUE AS WILL FIT BETWEEN THE JAWS WHERE THE CURRENT WILL PASS. IF THE VESSEL DIAMETER EXCEEDS 7 MM - OUT OF RANGE OF THE COAGULATING CURRENT - THE TISSUE MAY NOT COAGULATE, AND MAY BLEED WHEN CUT." "DEVICE IS FOR SOFT TISSUE ONLY! CORRECTLY POSITION THE TISSUE TO BE COAGULATED BETWEEN THE OPEN JAWS; THEN CLOSE THE JAWS ON THE TISSUE BY SQUEEZING THE HANDLES. IF TISSUE TREATED REQUIRES EXCESSIVE FORCE, DO NOT USE." THE DEVICE WAS RECEIVED WITH THE TOP OF THE I-BLADE FRACTURED AND SLIGHTLY LIFTED. BOTH JAWS ARE COMPLETELY DETACHED FROM THE INSTRUMENT (PIECES RETURNED); THE ELECTRODE AND THE ACTIVE ROD ARE MISSING AS WELL. THE DAMAGED PORTION OF THE I-BLADE PREVENTS IT FROM RETAINING THE UPPER JAW, ALLOWING IT TO DETACH FROM THE INSTRUMENT. VISUAL INSPECTION WAS PERFORMED AND THE UPPER JAW IS SLIGHTLY BENT. THE BOTTOM JAW SHOWS GOOD WELD PENETRATION AND ALL OF THE WELD MATERIAL ARE STILL ATTACHED. DUE TO THE CONDITION OF THE RETURNED INSTRUMENT, NO MECHANICAL OR FUNCTIONAL TESTING COULD BE PERFORMED. IT IS POSSIBLE THAT, WHILE REMOVING THE HARD AND THICK "MYOMA", THE JAWS AND THE BLADE COULD HAVE BEEN DAMAGED DUE TO EXCESSIVE FORCE AND TORSION BEING APPLIED RESULTING IN THE EVENTUAL DETACHMENT FROM THE INSTRUMENT. IN ADDITION, THIS COULD HAVE POSSIBLY CAUSED FOR THE ELECTRODE TO SEPARATE FROM THE CERAMIC, RESULTING IN THE REPLACE LIGHT ILLUMINATED WHEN THE JAWS WERE CLOSED. THIS MAY HAVE AFFECTED THE SEALING PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC MYOMECTOMY PROCEDURE, THE JAWS ON DEVICE BROKE. THE PROBLEM OCCURRED WHILE SEVERELY TORQUING THE DEVICE WHEN REMOVING A FIST-SIZED MYOMA. WHEN THE SURGEON ATTEMPTED TO PULL THE DEVICE THROUGH THE TROCAR, THE PIECES OF JAW FELL INTO THE PATIENT. THE CASE WAS CONVERTED TO AN OPEN PROCEDURE TO LOCATE AND REMOVE THE PIECES. THE PATIENT WAS X-RAYED SEVERAL TIMES TO BE SURE NO PIECES WERE LEFT INSIDE. IT WAS ALSO STATED THAT THE BLOOD LOSS WAS HIGHER THAN USUAL BUT NO QUANTITY WAS GIVEN. NO BLOOD PRODUCTS WERE NEEDED. ADDITIONAL INFORMATION FROM ACCOUNT: LOCAL SOURCES IN CASE (CIRCULATION AND SCRUB TECH) ADVISED THAT THE MYOMA WAS FIST SIZED AND VERY HARD. HOSPITAL DOES NOT HAVE A MORCELATOR. SURGEON WAS ATTEMPTING TO USE END OF JAW AS A GRASPING AND DISSECTING TOOL [NOT INTENDED USE OF DEVICE] TO DISSECT PORTIONS OUT OF MYOMA OUT UNTIL END OF JAW BROKE FROM TORQUING (OFF LABEL USE PER OR SOURCE). CANNULA OF TROCAR DISLODGED THE JAWS OF THE INSTRUMENT DURING REMOVAL FROM TROCAR. CONVERT TO OPEN WAS BOTH TO REMOVE THE MYOMA AND TO RETRIEVE PIECES. OR ADVISED SHOULD THIS PROCEDURE SHOULD HAVE BEEN OPEN TO BEGIN WITH DUE TO THE SIZE OF THE MYOMA. SALES REP ADVISED THAT THE MORE THAN AVERAGE BLEEDING MAY BE DUE TO SURGEON USING ENSEAL TO DISSECT TO MYOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NSEAL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK G4TM02

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR