BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 4921605 · Received July 17, 2015

    Report

    Report Number
    3005075853-2015-04367
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    March 23, 2015
    Report Date
    July 2, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT MEDICAL OPINION: LOOKS LIKE A PARTIAL THICKNESS BURN, MOSTLY ON THE SUPERIOR ASPECT OF THE WOUND. DO NOT PAY ATTENTION TO THE ECCHYMOSIS. THIS IS NOT DAMAGED TISSUE. I¿LL BET A MONOPOLAR WAS USED TO RAISE THE SKIN FLAPS, NOT HARMONIC. ADDITIONAL INFORMATION RECEIVED FROM PATIENT: THE MASTECTOMY WAS PERFORMED (B)(6) 2015 AT (B)(6) HOSPITAL, (B)(6) BY (B)(6). I DO NOT KNOW WHICH SPECIFIC HARMONIC SCALPEL WAS USED (PRODUCT NAME OR CODE). I ASSUME IT WAS USED TO CLOSE BLOOD VESSELS. I DO NOT KNOW WHICH VESSELS. I AM NOT AWARE ANY OTHER INSTRUMENT CAUSED OR WAS CAPABLE OF CAUSING, A BURN. I DO NOT KNOW WHICH PART OF THE HARMONIC SCALPEL CAUSED THE BURN. I FIRST NOTED THE BURN A COUPLE OF DAYS POST-OP. IT DID NOT LOOK LIKE THE INCISION MADE FOR ANY OF THE SEVERAL OTHER SURGERIES I HAVE HAD. I HAVE NO KNOWLEDGE OF ANY OF THE HOSPITAL STAFF INSERVICES. I WILL ATTEMPT TO SEND YOU ONE OF THE FIRST PHOTOS TAKEN BY ME. I ATTEMPTED TO REACH THE RISK MANAGER BUT RECEIVED NO RESPONSE.

    Description of Event or Problem · 1

    PER MAUDE EVENT REPORT #MW5042174, DURING A MASTECTOMY PROCEDURE; THE DEVICE WAS USED TO CONTROL BLOOD LOSS. THERE WERE SECOND AND THIRD DEGREE BURNS ALONG THE ENTIRE EIGHT AND ONE INCH INCISION LINE. THE BURNS HAVE NOT YET HEALED. THE ESCHAR IS VERY DEEP AND HEALING IS VERY SLOW. THE BURNED AREA IS ONE A ONE HALF INCHES WIDE AT IT¿S GREATEST WIDTH. THE DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465151 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR AND HANDPIECE