BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 23CM W ERG HANDLE

    MDR report key: 1830285 · Received September 10, 2010

    Report

    Report Number
    3005075853-2010-05192
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 19, 2010
    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
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS CONFIRMED THAT THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND MISSING. THE REMAINING BLADE PORTION WAS SCRATCHED. DURING FUNCTIONAL TESTING ON A GENERATOR THE DEVICE GAVE AN ERROR CODE 5. THE DEVICE WAS DISASSEMBLED AND A BREAK WAS FOUND INSIDE THE TUBE PROXIMAL TO THE TISSUE PAD. THE ANALYSIS CONCLUDED THAT THE BLADE CRACKED DUE TO CONTACT WITH THE INNER TUBE. THIS DAMAGE WAS MOST LIKELY DUE TO EXCESSIVE SIDE FORCES APPLIED TO THE BLADE WHILE ACTIVATING RESULTING IN BLADE CONTACT WITH THE INNER TUB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE INSTRUMENT JAW BROKE (TITANIUM BLADE TIP) DURING A PROCEDURE (DID NOT FALL INTO THE PATIENT) ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "SURGEON IMPLANTED OMI-FIT HFX PRESSFIT STEM, AND A # 9 C-TAPER. HE THEN IMPLANTED 26MM, 0 C-TAPER LFIT HEAD. THE 26MM, 0 C-TAPER DID NOT ENGAGE ON STEM TRUNNION. THE SURGEON WENT TO THE NEXT SIZE, 26MM +5 WHICH ENGAGED PROPERLY TO THE EXCISING TRUNNION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 23CM W ERG HANDLE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK F4PH68

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE