BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1851669 · Received October 4, 2010

    Report

    Report Number
    3005075853-2010-05661
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE TISSUE PAD PARTIALLY DETACHED AND THE BLADE SCRATCHED. THE TISSUE PAD WAS FOUND WITH B-FORM STAPLES EMBEDDED, EVIDENCE THAT THE BLADE HAD BEEN IN CONTACT WITH ANOTHER METAL. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL. IT IS PROBABLE THAT THE CONTACT BETWEEN THE CONTACT BETWEEN THE B-FORM STAPLES AND THE TISSUE PAD WHEN THE CLAMP ARM WAS CLOSED AND THE BLADE WAS ACTIVATED MAY HAVE DAMAGED THE TISSUE PAD AND THE BLADE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TISSUE PAD OF THE DEVICE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 7700 SYSTEM LOCKED UP AND APPEARED TO CONTINUE TO FLUORO. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE