BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1914165 · Received December 3, 2010

    Report

    Report Number
    3005075853-2010-06844
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    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. 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.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REGARDING A POWER FAILURE ON THE HOMECHOICE (HC) MACHINE DURING INITIAL DRAIN. THE HP STATED THAT THE HC STARTED SMELLING AS IF IT WAS BURNING AND HE HEARD CRACKLING. THE HP STATED HE UNPLUGGED THE MACHINE AND DISCONNECTED. THE HP CONFIRMED THE OUTLET WORKED OKAY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INITIATED A SWAP OF THE DEVICE. THE HP CONFIRMED HE WOULD HAVE HIS NURSE (RN) PROGRAM THE NEW CYCLER. THE HP STATED HE HAD MANUAL SUPPLIES. THE HP ALSO STATED HE WAS DIABETIC AND USES INSULIN SO HE WOULD CALL HIS NURSE ABOUT USING MANUAL SUPPLIES. THE PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BLADE BROKE OFF OUTSIDE THE PATIENT, AN ERROR FIVE WAS DISPLAYED. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT OF THE RIGHT VENTRICULAR LEAD, THE HELIX WOULD NOT EXTEND. THE LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    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