BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2992904 · Received March 7, 2013

    Report

    Report Number
    3005075853-2013-01113
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 22, 2013
    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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE A AND B WERE RETURNED WITH THE BLADE SCRATCHED AND CRACKED. EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. DEVICE C WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND RETURNED WITH THE DEVICE. THE REMAINING BLADE PORTION WAS SCRATCHED - EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. THE DEVICES WERE FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON GEN11 AN INSTRUMENT ERROR SCREEN WAS RECEIVED. A PROBABLE CAUSE OF THE DEVICE TO STOP ACTIVATING AND DISPLAY AN INSTRUMENT ERROR SCREEN IS BLADE DAMAGE. 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 YELLOW ALERT SCREENS, SUCH AS "REPLACE INSTRUMENT" WITH THE GEN11 LATER IN THE PROCEDURE, AND CONTINUED USAGE CAN RESULT IN A BROKEN BLADE. THE "TIGHTEN ASSEMBLY" YELLOW SCREEN APPEARS WHEN THE INSTRUMENT MAY NOT BE PROPERLY ASSEMBLED TO THE HANDPIECE. DEVICE B ADDITIONAL INFORMATION: BATCH # J92H02, EXPIRATION DATE: 09/10/2017, MANUFACTURING DATE: 10-10-2012. DEVICE C ADDITIONAL INFORMATION: BATCH # J92U0F, EXPIRATION DATE: 10-12-2017, MANUFACTURING DATE: 11-12-2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VIDEO-ASSISTED LAPAROSCOPIC ESOPHAGUS RESECTION AFTER APPROXIMATELY 30 MINUTES (ACE PERFORMED WELL BEFORE), GAVE THE GEN11 AN ERROR "TIGHTEN ASSEMBLY." THEY RE-ASSEMBLED THE HARMONIC ACE ON THE HANDPIECE BUT IT DIDN'T FUNCTION ANYMORE. HANDPIECE WAS CHANGED, BUT GAVE THE SAME ERROR CODE AFTER STARTING UP. ANOTHER ACE WAS OPENED. THE MEDICAL TECHNICIAN CHECKED OUT THE BIOMED SETTINGS. HE COULD ONLY SEE: THE TIME OF ACTIVATION/HOW LONG THE SURGEON HAS WORKED WITH THE ACE. THAT THE DEVICE WAS DIRTY. AND THE TIGHTEN ASSEMBLY ERROR. THE DEVICE WITH LOT NUMBER J92U0F HAS AS ADDITIONAL PROBLEM THAT THE BLADE BROKE OFF. LIGASURE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED. THREE DEVICES WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97081 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE