BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1963454 · Received January 19, 2011

    Report

    Report Number
    3005075853-2011-00250
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 5, 2011
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. EVENT DATE: ONLY MONTH AND YEAR KNOWN, ASSUMED 1ST DAY OF MONTH (B)(6) THAT COMPLAINT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE (A) WAS RETURNED WITH THE TISSUE PAD MELTED AND PARTIALLY DETACHED WITH THE BLADE GOUGED AT THE TIP. THE DEVICE WAS TESTED WITH A TEST HANDPIECE AND GENERATOR AND ERROR CODE 5 WAS RECEIVED, NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED. PROBABLE CAUSES OF BLADE DAMAGE ARE EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE, BLADE CONTACT WITH OTHER DEVICES, STAPLES OR CLIPS DURING THE PROCEDURE OR USING ANY MEANS OTHER THAN THE BLADE WRENCH TO ATTACH OR DETACH THE BLADE. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE DAMAGE SEVERITY AND RESULT IN BLADE "LOCKOUT" LATER IN THE PROCEDURE. PROBABLE CAUSES OF THE TISSUE PAD DAMAGE IS APPLYING PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. AND ACTIVATING THE BLADE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE TISSUE PAD. BOTH CONDITIONS CAN RESULT IN PROBABLE DAMAGE TO THE INSTRUMENT. DEVICE B WAS RETURNED WITH THE TISSUE PAD MISSING AND THE BLADE GOUGED AT THE TIP. WHEN THE TISSUE PAD IS DISPLACED, THE CLAMP ARM MAY DAMAGE THE BLADE BY COMING IN CONTACT WITH THE TIP. THE DEVICE MAY STOP ACTIVATING, AND EITHER EMIT A SOLID TONE OR DISPLAY AN INSTRUMENT ERROR CODE 5 ON THE GENERATOR DISPLAY WHEN THE BLADE IS DAMAGED. AS THE TISSUE PAD WAS NOT RETURNED, FURTHER EVALUATION COULD NOT BE PERFORMED. DEVICE B BATCH G9LM9V MFG DATE 12-2-2010, EXP DATE 11-2-2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC NISSEN HIATAL HERNIA PROCEDURE, THE FIRST DEVICE BEING USED THE WHITE PAD FELL OFF OF THE DEVICE THE SECOND DEVICE THE PAD MELTED. THE PAD IS SLIPPING OFF OF THE CLAMP ARM BUT STILL ATTACHED. IT IS UNKNOWN IF ANY PIECE FELL INTO THE PATIENT AT THIS TIME. THEY USED A THIRD DEVICE TO COMPLETE THE PROCEDURE. THEY DID NOT CONVERT TO AN OPEN PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36CM W ERG HANDLE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK G9LM9V

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE