BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2874094 · Received December 14, 2012

    Report

    Report Number
    3005075853-2012-05733
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 4, 2012
    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
    NY, US
    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 RETURNED WITH THE OUTER TUBE (SHAFT) BENT AND WITH THE CLAMP ARM DETACHED FROM THE INNER TUBE, BUT FIRMLY FIXED TO THE OUTER TUBE AT THE CLAMP ARM WELD. THE TISSUE PAD WAS FOUND IN GOOD PHYSICAL CONDITION AND PROPERLY ATTACHED TO THE CLAMP ARM. FUNCTIONAL TESTING COULD NOT BE PERFORMED, AS IT DID NOT ENGAGE WITH THE HAND PIECE, DUE TO THE CONDITION OF THE SHAFT. IT WAS DIFFICULT TO ROTATE THE SHAFT WHEN THE INSTRUMENT WAS TRIED TO BE ATTACHED TO THE HAND PIECE. IT IS POSSIBLE THAT THE DAMAGE IN THE METAL RING, OR THE BENT SHAFT DID NOT ALLOW THE DEVICE TO BE TORQUED PROPERLY. THE HOUSING OF THE HAND ACTIVATION CONTACTS IS DAMAGED. IT SHOULD BE NOTED THAT AT LEAST 200% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WOULD NOT CONNECT TO THE HANDPIECE. THIS IS ALL THE INFORMATION THAT THE CUSTOMER HAD AT THE TIME OF THE CALL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR 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 J90G4P

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE