BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3851881 · Received June 5, 2014

    Report

    Report Number
    3005075853-2014-03811
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS RECEIVED WITH THE SHAFT BENT. THE DEVICE WAS CONNECTED TO THE GENERATOR AND IT WAS RECOGNIZED BUT DUE TO THE CONDITION OF THE DEVICE NOT ALL FUNCTIONAL TESTING COULD BE PERFORMED AND WE COULD NOT TEST THE DEVICE FOR THE REPORTED ISSUE. NO CONCLUSION COULD BE REACHED AS TO HOW THE SHAFT BECAME BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE GENERATOR DISPLAYED CONSTANT ERROR MESSAGES WHICH COULD NOT BE RESOLVED, EVEN WHEN CONNECTING A SECOND HANDPIECE. NEW SHEARS HAD TO BE OPENED TO CONTINUE. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328527 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE