BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO 3MM CURVE TIP 35CM

    MDR report key: 1790266 · Received August 10, 2010

    Report

    Report Number
    3005075853-2010-04543
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 16, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES WERE SENT TO THE CINCINNATI PI LAB FOR ADDITIONAL TESTING. THE DEVICES HAD BEEN RETURNED WITH THE CABLE CUT OFF; THEREFORE FUNCTIONAL TESTING COULD NOT OCCUR,. DEVICE A: THERE WAS A GAP AT THE DISTAL END OF THE TOP JAW. ON THE INSIDE OF THE CURVE THERE WAS A CRACK IN THE GLUE BETWEEN THE ELECTRODE AND CERAMIC. THIS DEVICE ALSO HAD A BENT TOP HEAD ON THE I-BEAM AND THE BOTTOM HEAD WAS NOT RIDING AGAINST THE JAW IN THE FULLY CLOSED POSITION. DEVICE B: THERE WAS A GAP AT THE DISTAL END OF THE TOP JAW. ON THE INSIDE OF THE CURVE THERE WAS A CRACK IN THE GLUE BETWEEN THE ELECTRODE AND CERAMIC. THIS DEVICE ALSO HAD A BENT TOP HEAD ON THE I-BEAM AND THE BOTTOM HEAD WAS NOT RIDING AGAINST THE JAW IN THE FULLY CLOSED POSITION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE'S CORD CUT OFF; UNABLE TO PERFORM FUNCTIONAL ANALYSIS THE DEVICE A WAS RECEIVED WITH THE POWER CORD CUT OFF. DUE TO THE RETURNED CONDITION, NO FUNCTIONAL TESTING COULD BE PERFORMED AS THE DEVICE COULD NOT BE PLUGGED INTO THE RF-60 AND ACTIVATED. HOWEVER, WE WERE ABLE TO ACTUATE TEST THE DEVICE HANDLE, NO CRACKING SOUNDS WERE HEARD WHEN THE DEVICE WAS CLAMPED ON THE TEST MEDIA. THE DEVICE B WAS RECEIVED WITH THE POWER CORD CUT OFF. DUE TO THE RETURNED CONDITION, NO FUNCTIONAL TESTING COULD BE PERFORMED AS THE DEVICE COULD NOT BE PLUGGED INTO THE RF-60 AND ACTIVATED. WE WERE ABLE TO ACTIVATE THE DEVICE HANDLE AND DURING THIS TEST, THE JAWS DID NOT LOCK ONTO THE TEST MEDIA.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A PORTABLE OXYGEN CONCENTRATOR POWER CORD WAS EMITTING SMOKE AND SPARKS. THE POWER CORD WAS RETURNED TO THE MFR AND WAS VISUALLY INSPECTED. THE POWER CORD HAD EVIDENCE OF PHYSICAL AND THERMAL DAMAGE. THERE WAS NO REPORT OF PT HARM OR INJURY. THE MFR IS CURRENTLY INVESTIGATING THIS ISSUE AND A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE FIRST DEVICE WAS CLAMPED ON TISSUE THEN MADE A CRACKING SOUND THEN STOPPED WORKING. THE SECOND DEVICE TOOK 3 OR 4 BITES THEN LOCKED ON TISSUE. IT IS UNKNOWN HOW THE DEVICE WAS REMOVED EVENTUALLY THE JAWS OPENED. THE THIRD DEVICE DID NOT GENERATE ENOUGH POWER FOR COAGULATION. THERE WAS MORE BLEEDING THAN NORMAL HOWEVER THE AMOUNT OF BLOOD LOSS IS UNKNOWN. THERE WAS NO BLOOD TRANSFUSION NEEDED. A BIPOLAR DEVICE WAS USED TO CONTROL THE BLEED AS WELL AS TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL TRIO 3MM CURVE TIP 35CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK G4T37D

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR