BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2873343 · Received December 14, 2012

    Report

    Report Number
    3005075853-2012-05719
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 1, 2012
    Report Date
    December 4, 2012
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE 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 DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON THE GEN11 GENERATOR, THE 'INSTRUMENT ERROR' ALERT WAS DISPLAYED; AND WHEN TESTED ON THE GEN04 GENERATOR, AN ERROR CODE 5 (INSTRUMENT ERROR) WAS DISPLAYED. A PROBABLE CAUSE OF THE DEVICE STOP ACTIVATING AND DISPLAY AN ERROR CODE 5 OR 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS SHOULD THE DEVICE BE RETURNED FOR ANALYSIS, A SUPPLEMENTAL MEDWATCH WILL BE SENT

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED: THE HARMONIC BLADES ARE MADE OF TITANIUM, WHICH IS VERY HARD METAL. THE TITANIUM BLADE TIP WILL NOT BREAK OFF UNLESS IT HAS BEEN CRACKED. THE HARMONIC BLADE WILL STOP ACTIVATING, AND EITHER EMIT A SOLID TONE AND/OR DISPLAY AN INSTRUMENT ERROR CODE WHEN THE BLADE HAS BECOME CRACKED (BUT NOT SCRATCHED, NICKED OR GOUGED). ONCE THE BLADE IS CRACKED, IT IS SUSCEPTIBLE TO BREAKING OFF DUE TO CONTINUED ATTEMPTS TO ACTIVATE OR FROM PHYSICAL CONTACT. BLADE DAMAGE IS CAUSED BY CONTACTING AN ACTIVE BLADE WITH OTHER SURGICAL DEVICES, STAPLES OR CLIPS DURING THE PROCEDURE OR USING ANY MEANS OTHER THAN THE BLADE WRENCH TO ATTACH OR DETACH THE BLADE. ONCE BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY RESULT IN FATIGUE FAILURE INITIATING AT THE ORIGINAL DAMAGE LOCATION, WHICH CAN RESULT IN THE BLADE TIP BREAKING OFF AS DESCRIBED ABOVE. DOES THE ACCOUNT REPROCESS HARMONIC DEVICES - MEANING THAT THE DEVICE WAS USED ON ONE PATIENT, THEN CLEANED AND RESTERILIZED AND USED ON ANOTHER PATIENT?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE HAD BEEN SET UP FOR A CASE AND BEFORE BEING USED THE TIP FELL OFF (TIP = ACTIVE BLADE). NO PROBLEM TO THE PATIENT. NO REAL SURGICAL DELAY. THE DEVICE WAS REPLACED WITH ANOTHER SAME PRODUCT TO COMPLETE THE CASE. THE DEVICE WAS REPORTED AS BEING SET UP PROPERLY AND NO FORCE HAD BEEN APPLIED TO THE TIP THAT WOULD CAUSE IT TO 'FALL OFF.' ONE DEVICE WILL BE RETURNING.

    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