BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL SUPER JAW

    MDR report key: 2871803 · Received December 13, 2012

    Report

    Report Number
    3005075853-2012-05671
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 INFORMATION REQUESTED: DID THE SURGEON ATTEMPT TO MANUALLY OPEN THE JAWS WITH HIS FINGERS? IF NO: WAS THE DEVICE ON A VESSEL/ARTERY WHEN IT WOULD NOT OPEN? IF YES, HOW WAS THE DEVICE REMOVED? (I.E. CUT OFF, FORCED OPENED); IF CUT OFF, DID THIS CAUSE A CHANGE IN THE PLAN OF CARE FOR THE PATIENT? DID THE REMOVAL CAUSE ANY DAMAGE TO THE VESSEL/ARTERY? IF YES, WHAT IS THE DAMAGE AND HOW WAS THE DAMAGE REPAIRED? WITH MOD03 G2 SUPER JAW DEVICE: THIS IS A MOD 03 DEVICE THAT HAS A LIGHTER RETURN SPRING. THE LIGHTER SPRING WAS A TRADE OFF TO REDUCE THE FORCE TO FIRE. THIS DEVICE DOES REQUIRE THE HANDLE TO BE PUSHED OPEN TO OPEN THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED JAW STUCK SHUT THE DEVICE WAS TESTED ON THE GENERATOR AND PASSED ALL FUNCTIONAL TESTING. THE ENERGY OUTPUT DELIVERED FROM THE DEVICE WAS VERIFIED AND THE CUTTING OF THE TEST MEDIA PERFORMED AS EXPECTED. ALL THREE TONES WERE HEARD DURING FUNCTIONAL TESTING (TONE 1 IS HEARD WHEN THE ENERGY ACTIVATION BUTTON IS PRESSED; TONE 2 IS HEARD WHEN TISSUE IMPEDANCE THRESHOLD IS REACHED; AND TONE 3 IS HEARD WHEN THE CYCLE IS COMPLETE). DURING FUNCTIONAL TESTING, THE BLADE RETURNED AFTER THE HANDLE WAS DEPRESSED AND THE JAWS OPENED AND CLOSED DURING ALL TESTS. THE KNIFE BLADE WAS BUCKLED BUT NOT ENOUGH TO AFFECT OPENING AND CLOSING.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL ANALYSIS RESULTS: THE SECTOR GEAR HAD TWO TEETH THAT FRACTURED, WITH BOTH OF THE TEETH STILL PARTIALLY ATTACHED. SEM ANALYSIS SHOWED NO EVIDENCE OF A GREEN STATE CRACK. THE FRACTURE CONSISTED OF A MIX OF DUCTILE DIMPLES AND SMOOTH SURFACES INDICATIVE OF NORMAL POWDER METALLURGY PART. THE SIDE OF THE TEETH SHOWED EXTENSIVE INDENTS AND SECONDARY CRACKING INDICATING THAT THE TEETH HAD BEEN EXPOSED TO A HIGH LOAD. THESE TEETH FRACTURED DUE TO AN EXCESSIVE LOAD CAUSING THEM TO BREAK IN A DUCTILE OVERLOAD MANNER. THE PROXIMAL GEAR ALSO HAD SEVERAL TEETH BREAK. NO GREEN STATE CRACKS WERE OBSERVED ON ANY OF THE FRACTURE SURFACE. THESE FRACTURES ALSO APPEARED SIMILAR TO THE SECTOR GEAR. THEY WERE WAS A MIX OF DUCTILE DIMPLES AND SMOOTH SURFACES INDICATIVE OF A NORMALLY PROCESSED POWDER METALLURGY. THERE WAS NO EVIDENCE OF A MATERIAL DEFECT IN THE TEETH ON EITHER OF THE PARTS EXAMINED. ALL OF THE TEETH FAILED AS A RESULT OF A LOAD IN EXCESS OF THE MATERIAL STRENGTH OF THE TEETH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BOWEL OBSTRUCTION PROCEDURE, THE SURGEON ATTEMPTED TO PULL BACK THE JAWS AND THEY WOULD NOT RELEASE. NO MESSAGE WAS DISPLAYED ON THE GENERATOR. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    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 J4C81P

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE