BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1914140 · Received December 3, 2010

    Report

    Report Number
    3005075853-2010-06841
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 11, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN'S (B)(4) HANDHELD DEVICE WOULD NOT TURN ON. THE PHYSICIAN STATED THE HANDHELD DEVICE WAS PLUGGED IN (CHARGED) OVERNIGHT, HOWEVER, IT WOULD NOT TURN ON. A REPLACEMENT HANDHELD DEVICE WAS SENT TO THE PHYSICIAN. GOOD FAITH ATTEMPTS TO OBTAIN THE DELL X5 HANDHELD DEVICE IN QUESTION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER RECEIVING AN ERROR CODE 5, HE DEVICE WAS REMOVED FROM THE PATIENT, RETIGHTENED AND CLEANED. WHEN THE DEVICE WAS INSERTED BACK INTO THE PATIENT, IT WAS NOTICED THAT THE BLADE TIP WAS MISSING. THE BLADE COULD NOT BE LOCATED AT THE TIME AND THE CASE WAS COMPLETED USING A BIPOLAR DEVICE. THE BLADE TIP WAS EVENTUALLY FOUND IN THE TRASH WHERE THE DRAPE WAS DISCARDED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    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 GENERATOR AND HANDPIECE