BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2990017 · Received March 5, 2013

    Report

    Report Number
    3005075853-2013-01038
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 19, 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
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 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). CORRECTION - NOT REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NEPHRECTOMY CASE, THE SCRUB NURSE HAD CHECKED THE DEVICE AND IT WAS IN GOOD CONDITION AND PASSED THE TESTING PROCESS. THE TISSUE PAD IS SEPARATED FROM THE CLAMPING SURFACE AFTER USING ACTIVATION NOT MORE THAN 20 TIMES, AND CANNOT ACTIVE WITHOUT TISSUE. THE SURGEON THINKS THAT IT IS NOT ACCEPTABLE THAT THE WHITE PLASTIC IS SEPARATED FROM THE CLAMPING SURFACE FOR SUCH A SHORT TIME AND NEVER HAPPEN IN HIS USING 100 TIMES EXPERIENCE. ONE DEVICE IS RETURNING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - TISSUE PAD WAS MELTED AND PARTIALLY DETACHED BUT DID NOT FALL OFF THE CLAMP ARM. FILE IS NOT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93860 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE