BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 23 CM

    MDR report key: 1790253 · Received August 10, 2010

    Report

    Report Number
    3005075853-2010-04540
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 16, 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

    INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS SHOWED THAT THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED WITH THE DEVICE. THE REMAINING BLADE PORTION WAS SCRATCHED. THE DEVICE WAS ACTIVATED WITH THE GENERATOR AND AN ERROR CODE 5 WAS DISPLAYED. PROBABLE CAUSES OF BLADE DAMAGE, INCLUDING BREAKAGE, 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 AN ERROR CODE 5 OR BLADE LOCKOUT LATER IN THE PROCEDURE, AND CONTINUED USAGE CAN RESULT IN A BROKEN BLADE

    Description of Event or Problem · 1

    SURGEON REPORTED A CRANIAL TUMOR BIOPSY ON A PT WITH A 5MM DIAMETER TUMOR CAME BACK WITHOUT A TUMOR SAMPLE. THE SURGEON CONFIRMED THAT THE NEEDLE MISSED THE LESION BY A COUPLE MILLIMETERS VIA POST-OPERATIVE SCAN. THE PT REQUIRED ANOTHER SURGERY SINCE THIS ONE DID NOT PRODUCE A SAMPLE DUE TO THE INACCURACY. FOR THE SECOND SURGERY, THE SURGEON USED A STEREOTACTIC LEKSELL FRAME WITH THE STEALTHSTATION FRAMELINK APPLICATION. A TUMOR SAMPLE WAS SUCCESSFULLY OBTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TITANIUM TIP OF THE SCALPEL WAS BROKEN. THE BROKEN PART DID NOT FALL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 23 CM INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1