BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO 3MM CURVE TIP 35CM

    MDR report key: 1882626 · Received October 26, 2010

    Report

    Report Number
    3005075853-2010-06077
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED INFORMATION THE DEVICE WAS RECEIVED WITH THE ELECTRODE SEPARATED FROM THE CERAMIC. THE CERAMIC IS NOT DAMAGED AND IS SECURELY BONDED TO THE BOTTOM JAW. DUE TO THE CONDITION OF THE ELECTRODE, NO FUNCTIONAL TESTING WAS PERFORMED. THE LACK OF RESIDUAL ADHESIVE ALONG THE SURFACE OF THE CERAMIC SUGGESTS ADHESION FAILURE DUE TO POOR SURFACE PREPARATION DURING ASSEMBLY. IT IS POSSIBLE THAT THE SEPARATED ELECTRODE COULD HAVE AFFECTED THE SEALING PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLON RESECTION PROCEDURE, THE DEVICE WAS MAKING A STRANGE BEEPING SOUND AND THEY WERE NOT GETTING PROPER TISSUE REACTION. THEY WERE NOT GETTING COAGULATION OR SEALING. NO SIGNIFICANT BLOOD LOSS. ANOTHER LIKE DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, THE MONITORS WENT BLANK AND THE SYSTEM IS NOT WORKING. NO PT INJURY WAS REPORTED.

    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 G4TT80

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR