BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 23CM W ERG HANDLE

    MDR report key: 1160684 · Received September 5, 2008

    Report

    Report Number
    3005075853-2008-01544
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 09/05/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A OPEN COLECTOMY. THE DEVICES WERE BEING USED ON THE COLON, IT WAS LAID ON THE FIELD AND WAS UP AGAINST THE NURSE'S SURGICAL GOWNS, IT BURNED A HOLE THROUGH TWO DIFFERENT NURSE'S GOWN. THE TIP SEEMS TO BE HOTTER THAN USUAL. THE CORD WAS TESTED WITH THE BIOMED AND EVERYTHING WAS FINE WITH THE HANDPIECE BEING USED. ANOTHER DEVICE DIFFERENT PRODUCT CODE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 23CM W ERG HANDLE LFL ETHICON ENDO-SURGERY, LLC NA E4L015

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR