BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3893860 · Received June 25, 2014

    Report

    Report Number
    3005075853-2014-04360
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH TISSUE PAD LIFTED AT THE TIP OF THE CLAMP ARM. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE SHAFT OF THE DEVICE WAS SLIGHTLY BENT. BASED ON THE CONDITION OF THE TISSUE PAD, A POSSIBLE CAUSE FOR THIS DAMAGE IS THAT THE TISSUE PAD GOT STUCK ON A TROCAR OR BODY TISSUE; HOWEVER NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. CARE SHOULD BE TAKEN WHEN INTRODUCING THE INSTRUMENT INTO A TROCAR OR DURING USE INSIDE THE PATIENT. CLEANING OF THE PAD, NOT IN ACCORDANCE WITH THE IFU, CAN ALSO RESULT IN REMOVAL OF THE PAD DURING USE. HOWEVER, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND DAMAGE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY PROCEDURE, THE WHITE TISSUE PAD WAS MELTED BUT STILL IN THE CLAMP ARM. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371129 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE