BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2162416 · Received July 14, 2011

    Report

    Report Number
    3005075853-2011-02884
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    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): ADDED ADDITIONAL INFORMATION. THE DEVICE RECEIVED WAS RETURNED IN GOOD PHYSICAL CONDITION. THE TISSUE PAD WAS FOUND IN GOOD PHYSICAL CONDITION AND PROPERLY ATTACHED TO THE CLAMP ARM. IT IS POSSIBLE THAT THE DEVICE RETURNED MAY HAVE BEEN USED TO COMPLETE THE PROCEDURE AND IS NOT THE DEVICE COMPLAINED ABOUT. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TISSUE PAD OF THE SCALPEL FELL OFF AFTER BEING ACTIVATED 4 TIMES. THE TISSUE PAD WAS RETRIEVED BY FORCEPS THROUGH THE TROCAR. CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE