BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3864490 · Received June 10, 2014

    Report

    Report Number
    3005075853-2014-03908
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 5, 2014
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). POTENTIAL REPROCESSING; A NEW BLADE CANNOT BREAK UNLESS IT WAS CRACKED BY PRIOR USE. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION WITH THE BLADE TIP INTACT AND NOT BROKEN OFF AS REPORTED BY THE CUSTOMER. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON GEN11 AN ALERT SCREEN WAS DISPLAYED. THE DEVICE WAS DISASSEMBLED AND IT WAS FOUND THAT THE BLADE WAS CRACKED AT THE PIN HOLE UNDER THE SHROUD OF THE DEVICE. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE DAMAGE SEVERITY AND RESULT IN ALERT SCREENS, SUCH AS ¿TIGHTEN ASSEMBLY¿, ¿BLADE ERROR DETECTED¿ OR "RELAXED PRESSURE ON BLADE" FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN LATER IN THE PROCEDURE.

    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. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, AN INVESTIGATION COULD NOT BE PERFORMED. WE DID NOT RECEIVE A BATCH NUMBER OR LOT NUMBER SO THEREFORE WE WERE UNABLE TO REVIEW THE MANUFACTURING RECORDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, THE TITANIUM TIP BROKE DURING THE PRE-RUN TEST. THE BROKEN PIECE DID NOT FALL INTO THE PATIENT¿S BODY. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338955 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE