BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3122572 · Received May 21, 2013

    Report

    Report Number
    3005075853-2013-02463
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 30, 2013
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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: AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. SHOULD THE DEVICE BE RETURNED FOR ANALYSIS, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TISSUE PAD IS DETACHED INSIDE THE PATIENT AND HAS NEVER BEEN RETRIEVED. IT IS LOCATED IN THE POUCH OF DOUGLAS, THE PATIENT IS INFORMED ABOUT IT. ANOTHER DEVICE LIKE DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223836 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J90M2C

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE