BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1901042 · Received November 17, 2010

    Report

    Report Number
    3005075853-2010-06574
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDED ADDITIONAL INFORMATION THE DEVICE 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. WHEN A BLADE IS DAMAGED, IT MAY NOT COMPLETE THE PRE-RUN TESTING, WILL DISPLAY AN ERROR CODE AND WILL KEEP REVERTING BACK TO STANDBY MODE. IN ADDITION, MINOR BLADE DAMAGE MAY INCREASE IN SEVERITY DURING SUBSEQUENT ACTIVATIONS, AND MAY RESULT IN BLADE "LOCKOUT" LATER IN THE PROCEDURE. 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

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, A PIECE BROKE OFF THE DEVICE. IT WAS THE TIP. NO OTHER DETAILS OF THE EVENT ARE KNOWN. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR THORACIC AORTIC ANEURYSM IN ZONES 3 AND 4 APPROX 83 MONTHS AGO. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. IT WAS REPORTED 24 MONTHS POST STENT GRAFT IMPLANT THE PT HAD A TYPE III ENDOLEAK, SEPARATION RESULTING IN A CONTAINED RUPTURED ANEURYSM, AND WAS REPAIRED WITH ANOTHER MANUFACTURER¿S DEVICE. IT WAS REPORTED THAT THE SUBJECT RECENTLY HAD A CT SCAN WHICH REVEALED INTERVAL ENLARGEMENT OF THE TAA SECONDARY TO DEVICE FAILURE AS THERE IS A TOTAL POSTERIOR FRACTURE OF THE THORACIC STENT GRAFT. AT THIS TIME THE PHYSICIAN WILL MONITOR THE PT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. (2953200-2010-02316, 2953200-2010-02317).

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1