BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2243323 · Received September 12, 2011

    Report

    Report Number
    3005075853-2011-03735
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 26, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. 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 WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND 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. DEVICE B WAS RETURNED IN GOOD PHYSICAL CONDITION. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL; HOWEVER, IT OPENED WITH SOME DIFFICULTY. THE DEVICE WAS DISASSEMBLED AND INTERNAL INTERFERENCE BETWEEN MOVING PARTS WAS FOUND. THE HANDLE AND YOKE WERE RUBBING AGAINST EACH OTHER. THE YOKE IS AN INTERNAL MECHANISM THAT TRANSMITS THE FORCE AND MOTION FROM THE THUMB AND FINGER RINGS (HANDLE) INTO THE TUBE ASSEMBLY THAT CAUSES THE CLAMP ARM TO CLOSE. THIS FRICTION CAN HINDER THE ABILITY FOR THE USER TO OPEN AND CLOSE THE DEVICE EFFICIENTLY. DEVICE B BATCH H9116U MFG DATE 5-11-2011 EXP DATE 4-11-2016 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, THE BLADE OF THE 1ST DEVICE WAS BROKEN OFF BEFORE USE FOR PATIENT. THE CLAMP ARM OF THE 2ND DEVICE COULD NOT MOVE PROPERLY, SO IT WAS NOT USED FOR PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE