BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3872165 · Received June 13, 2014

    Report

    Report Number
    3005075853-2014-03980
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE SALES UNIT WAS RETURNED WITH SIX DEVICES. EACH DEVICE WAS RECEIVED INSIDE ITS STERILE AND CLOSED PACKAGE. UPON VISUAL INSPECTION OF ONE DEVICE IT WAS NOTED A FOREIGN MATTER INSIDE THE PACKAGE. THE FOREIGN MATTER WAS INSPECTED THROUGH MAGNIFICATION AND IT WAS CONFIRMED TO BE BIOLOGICAL MATTER THE PACKAGE WAS OPENED AND IT APPEARED THAT THE BIOLOGICAL MATTER (BUG) WAS ADHERED TO THE TYVEK; HOWEVER, NO DEFINITIVE CONCLUSION COULD BE REACHED AS TO THE ORIGIN OF THE MATTER FOUND. COMPLAINT WAS ESCALATED TO THE APPLICABLE FRANCHISE CAPA COUNCIL FOR REVIEW, FURTHER INVESTIGATION DETERMINATION, AND DECISION ON ADDITIONAL ACTION REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INCOMING/LABELING OPERATION FOUND THE FOLLOWING DEFECT. DETAILS OF THE DEFECT IS ORGANIC PARTICLE MATTER INSIDE POUCH. PRODUCT CODE IS ACE23J AND LOT IS L9134U.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349709 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA L9134U

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE